Trial Outcomes & Findings for Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer (NCT NCT03998566)

NCT ID: NCT03998566

Last Updated: 2023-02-27

Results Overview

Number of subjects with TraceIT procedure-related event which resulted in a delay in initiation for RT (radio-therapy).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: 2-6 week assessment post-procedure
• Results posted on: 2023-02-27

Participant Flow

Participant milestones

Measure	TraceIT Tissue Spacer TraceIT Tissue Spacer implantation: The TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care.
Overall Study STARTED	6
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer

Baseline characteristics by cohort

Measure	TraceIT Tissue Spacer n=6 Participants TraceIT Tissue Spacer implantation: The TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2-6 week assessment post-procedure

Population: Modified Intent to Treat (MITT)

Number of subjects with TraceIT procedure-related event which resulted in a delay in initiation for RT (radio-therapy).

Outcome measures

Measure	All TIPS Participant n=6 Participants Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.	6 Month Follow-up Post Radiation Therapy Number of subjects showing persistence and migration.	One or More Late (>3 Months) Subjects who have experienced one or more AEs more than 3 months after index procedure.	12 Month Subject outcomes at 12 Month follow-up visit	18 Month Subject outcome at 18 month follow-up visit
Safety Endpoint No	6 Participants	—	—	—	—
Safety Endpoint Yes	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 2-6 week assessment

Population: Modified Intent to Treat (MITT)

Number of subjects who were able to maintain safe duodenal dose constraints. RT benefits were assessed via comparison of pre- and post-TraceIT administration RT plans with consideration of the following: ability to maintain safe duodenal dose constraints, percent/volume of gross tumor volume/planning target volume (GTV/PTV) receiving prescription dose and overall duodenal dose/dose distribution.

Outcome measures

Measure	All TIPS Participant n=6 Participants Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.	6 Month Follow-up Post Radiation Therapy Number of subjects showing persistence and migration.	One or More Late (>3 Months) Subjects who have experienced one or more AEs more than 3 months after index procedure.	12 Month Subject outcomes at 12 Month follow-up visit	18 Month Subject outcome at 18 month follow-up visit
Radio-Therapy Benefits of TraceIT Yes	6 Participants	—	—	—	—
Radio-Therapy Benefits of TraceIT No	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 2-6 week assessment post-procedure

Population: Modified Intent to Treat (MITT)

Number of subjects who achieved Technical Success (the ability to place TraceIT and create space between the duodenum and head of pancreas (HOP).

Outcome measures

Measure	All TIPS Participant n=6 Participants Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.	6 Month Follow-up Post Radiation Therapy Number of subjects showing persistence and migration.	One or More Late (>3 Months) Subjects who have experienced one or more AEs more than 3 months after index procedure.	12 Month Subject outcomes at 12 Month follow-up visit	18 Month Subject outcome at 18 month follow-up visit
Feasibility of TraceIT Yes	6 Participants	—	—	—	—
Feasibility of TraceIT No	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 2-6 weeks and 6 month post procedure

Population: Modified Intent to Treat (MITT)

Characteristics of TraceIT persistence and migration were measured at 2 to 6 weeks and 6 months following injection. Persistence was measured at the 2 to 6 week and 6 month follow-ups by assessing whether a cohesive mass of water density fluid was present in the periduodenal space following the last radio therapy appointment. Migration of the TraceIT post Radiation was measured by CT scan taken at 2-6 weeks follow-up.

Outcome measures

Measure	All TIPS Participant n=6 Participants Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.	6 Month Follow-up Post Radiation Therapy n=6 Participants Number of subjects showing persistence and migration.	One or More Late (>3 Months) Subjects who have experienced one or more AEs more than 3 months after index procedure.	12 Month Subject outcomes at 12 Month follow-up visit	18 Month Subject outcome at 18 month follow-up visit
TraceIT Persistence (at 6-months Post-treatment) Persistence · No	0 Participants	2 Participants	—	—	—
TraceIT Persistence (at 6-months Post-treatment) Persistence · Yes	3 Participants	0 Participants	—	—	—
TraceIT Persistence (at 6-months Post-treatment) Migration · No	3 Participants	—	—	—	—
TraceIT Persistence (at 6-months Post-treatment) Migration · Yes	2 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 2-6 week assessment Post-procedure

Population: Modified Intent to Treat (MITT)

Maximum dose to the GTV while maintaining duodenal dose constraints

Outcome measures

Measure	All TIPS Participant n=6 Participants Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.	6 Month Follow-up Post Radiation Therapy Number of subjects showing persistence and migration.	One or More Late (>3 Months) Subjects who have experienced one or more AEs more than 3 months after index procedure.	12 Month Subject outcomes at 12 Month follow-up visit	18 Month Subject outcome at 18 month follow-up visit
Theoretical Dose Escalation From Post-TraceIT Treatment Plan	12.7 Gy Standard Deviation 19.7	—	—	—	—

SECONDARY outcome

Timeframe: 18 months post procedure

Population: Modified Intent to Treat (MITT)

Number of subject with Duodenal AE summarized by CTCAE grade and timing

Outcome measures

Measure	All TIPS Participant n=6 Participants Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.	6 Month Follow-up Post Radiation Therapy n=6 Participants Number of subjects showing persistence and migration.	One or More Late (>3 Months) n=6 Participants Subjects who have experienced one or more AEs more than 3 months after index procedure.	12 Month Subject outcomes at 12 Month follow-up visit	18 Month Subject outcome at 18 month follow-up visit
Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing Subjects who have one or more grade 1 duodenal AEs	6 participants	6 participants	4 participants	—	—
Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing Subjects who have one or more grade 2 duodenal AEs	4 participants	3 participants	3 participants	—	—
Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing Subjects who have one or more grade 3 duodenal AEs	2 participants	0 participants	2 participants	—	—
Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing Subjects who have one or more grade 4 duodenal AEs	0 participants	0 participants	0 participants	—	—
Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing Subjects who have one or more grade 5 duodenal AEs	0 participants	0 participants	0 participants	—	—
Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing Subjects who only have grade N/A duodenal AEs	0 participants	0 participants	0 participants	—	—
Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing Subjects who have one or more duodenal AEs	6 participants	6 participants	4 participants	—	—

SECONDARY outcome

Timeframe: 2-6 weeks post procedure

Population: Modified Intent to Treat (MITT)

Number of subjects with resection following the completion of radiation therapy (RT). Within 2-6 weeks after completion of therapy, subjects were restaged to determine whether they may progress for surgery (resection).

Outcome measures

Measure	All TIPS Participant n=6 Participants Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.	6 Month Follow-up Post Radiation Therapy Number of subjects showing persistence and migration.	One or More Late (>3 Months) Subjects who have experienced one or more AEs more than 3 months after index procedure.	12 Month Subject outcomes at 12 Month follow-up visit	18 Month Subject outcome at 18 month follow-up visit
Incidence of Resection Following the Completion of Radiation Therapy (RT) Yes	3 Participants	—	—	—	—
Incidence of Resection Following the Completion of Radiation Therapy (RT) No	3 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 18 months post procedure

Population: Modified Intent to Treat (MITT)

Progression-free survival is the interval between the start of induction chemotherapy (prior to Radiation Therapy) to the earliest treatment failure onset date, or death, in months. Overall survival is the interval between the start of induction chemotherapy (prior to radiation therapy) to death in month.

Outcome measures

Measure	All TIPS Participant n=6 Participants Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.	6 Month Follow-up Post Radiation Therapy Number of subjects showing persistence and migration.	One or More Late (>3 Months) Subjects who have experienced one or more AEs more than 3 months after index procedure.	12 Month Subject outcomes at 12 Month follow-up visit	18 Month Subject outcome at 18 month follow-up visit
Progression Free and Overall Survival Progression free survival (subjects with tumor progression event)	17.6 months Standard Deviation 4.7	—	—	—	—
Progression Free and Overall Survival Overall survival in subjects who died	20.0 months Standard Deviation 10.1	—	—	—	—

SECONDARY outcome

Timeframe: Changes in baseline at the Final RT appointment, 3 month, 6 month, 12 month and 18 month

Population: Modified Intent to Treat (MITT)

The EORTC QOL QLQ-C30 is a questionnaire used to assess patient-reported symptoms and outcomes during cancer treatment. The survey contains 28 questions scored on a 4-point Likert scale (1 = 'Not at all' to 4 'Very much') and 2 questions on a 7-point numerical scale (1 = 'Very poor' to 7 = 'Excellent').Questions are grouped into 15 categories containing 1 to 5 different questions per category. All scores were transformed to a 0-100 scale following instructions in the scoring manual. Raw scores calculated as the average of component items are then standardized using linear transformation to a score ranging from 0-100. Higher score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems.

Outcome measures

Measure	All TIPS Participant n=6 Participants Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.	6 Month Follow-up Post Radiation Therapy n=6 Participants Number of subjects showing persistence and migration.	One or More Late (>3 Months) n=6 Participants Subjects who have experienced one or more AEs more than 3 months after index procedure.	12 Month n=4 Participants Subject outcomes at 12 Month follow-up visit	18 Month n=1 Participants Subject outcome at 18 month follow-up visit
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) Change of Global health status	-6.7 Scores on a scale Interval -25.0 to 0.0	-11.1 Scores on a scale Interval -25.0 to 8.3	3.3 Scores on a scale Interval -33.3 to 25.0	-29.2 Scores on a scale Interval -33.3 to -25.0	0 Scores on a scale Interval 0.0 to 0.0
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) Physical functioning	1.3 Scores on a scale Interval 0.0 to 6.7	-17.8 Scores on a scale Interval -46.7 to 0.0	1.3 Scores on a scale Interval -13.3 to 20.0	-10.0 Scores on a scale Interval -20.0 to 0.0	-13.3 Scores on a scale Interval -13.3 to -13.3
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) Role Functioning	-13.3 Scores on a scale Interval -33.3 to 0.0	-50.0 Scores on a scale Interval -100.0 to 0.0	0 Scores on a scale Interval -33.3 to 0.0	-8.3 Scores on a scale Interval -16.7 to 0.0	-66.7 Scores on a scale Interval -66.7 to -66.7
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) Emotional Functioning	-5 Scores on a scale Interval -33.3 to 8.3	5.6 Scores on a scale Interval 0.0 to 8.3	6.7 Scores on a scale Interval -25.0 to 25.0	-20.8 Scores on a scale Interval -25.0 to -16.7	-33.3 Scores on a scale Interval -33.3 to -33.3
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) Cognitive Functioning	0 Scores on a scale Interval -16.7 to 33.3	-16.7 Scores on a scale Interval -50.0 to 0.0	3.3 Scores on a scale Interval 0.0 to 16.7	-8.3 Scores on a scale Interval -16.7 to 0.0	-33.3 Scores on a scale Interval -33.3 to -33.3
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) Social Functioning	20 Scores on a scale Interval 0.0 to 50.0	-5.6 Scores on a scale Interval -16.7 to 0.0	16.7 Scores on a scale Interval -16.7 to 50.0	-16.7 Scores on a scale Interval -33.3 to 0.0	-66.7 Scores on a scale Interval -66.7 to -66.7
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) Fatigue	11.1 Scores on a scale Interval 0.0 to 33.3	37 Scores on a scale Interval 0.0 to 66.7	11.1 Scores on a scale Interval 0.0 to 33.3	0 Scores on a scale Interval 0.0 to 0.0	33.3 Scores on a scale Interval 33.3 to 33.3
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) Nausea and Vomiting	13.3 Scores on a scale Interval 0.0 to 33.3	5.6 Scores on a scale Interval 0.0 to 16.7	-6.7 Scores on a scale Interval -16.7 to 0.0	0 Scores on a scale Interval 0.0 to 0.0	16.7 Scores on a scale Interval 16.7 to 16.7
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) Pain	3.3 Scores on a scale Interval -16.7 to 16.7	0 Scores on a scale Interval 0.0 to 0.0	-10 Scores on a scale Interval -16.7 to 0.0	-8.3 Scores on a scale Interval -16.7 to 0.0	50 Scores on a scale Interval 50.0 to 50.0
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) Dyspnea	-13.3 Scores on a scale Interval -33.3 to 0.0	-11.1 Scores on a scale Interval -33.3 to 0.0	-20 Scores on a scale Interval -66.7 to 0.0	0 Scores on a scale Interval 0.0 to 0.0	0 Scores on a scale Interval 0.0 to 0.0
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) Insomnia	-6.7 Scores on a scale Interval -66.7 to 33.3	11.1 Scores on a scale Interval 0.0 to 33.3	0 Scores on a scale Interval -33.3 to 33.3	16.7 Scores on a scale Interval 0.0 to 33.3	33.3 Scores on a scale Interval 33.3 to 33.3
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) Appetite loss	6.7 Scores on a scale Interval -33.3 to 33.3	33.3 Scores on a scale Interval 0.0 to 66.7	6.7 Scores on a scale Interval 0.0 to 33.3	0 Scores on a scale Interval 0.0 to 0.0	66.7 Scores on a scale Interval 66.7 to 66.7
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) Constipation	13.3 Scores on a scale Interval 0.0 to 66.7	-22.2 Scores on a scale Interval -33.3 to 0.0	-13.3 Scores on a scale Interval -33.3 to 0.0	0 Scores on a scale Interval 0.0 to 0.0	33.3 Scores on a scale Interval 33.3 to 33.3
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) Diarrhea	6.7 Scores on a scale Interval 0.0 to 33.3	0 Scores on a scale Interval -33.3 to 33.3	-6.7 Scores on a scale Interval -33.3 to 0.0	0 Scores on a scale Interval 0.0 to 0.0	0 Scores on a scale Interval 0.0 to 0.0
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) Financial Difficulties	6.7 Scores on a scale Interval 0.0 to 33.3	-11.1 Scores on a scale Interval -33.3 to 0.0	0 Scores on a scale Interval -33.3 to 33.3	16.7 Scores on a scale Interval 0.0 to 33.3	0 Scores on a scale Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 2-5 weeks assessment post procedure

Population: Modified Intent to Treat (MITT)

Scores for the visualization of the fiducial marker and TraceIT hydrogel.

Outcome measures

Measure	All TIPS Participant n=6 Participants Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.	6 Month Follow-up Post Radiation Therapy Number of subjects showing persistence and migration.	One or More Late (>3 Months) Subjects who have experienced one or more AEs more than 3 months after index procedure.	12 Month Subject outcomes at 12 Month follow-up visit	18 Month Subject outcome at 18 month follow-up visit
Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel Fiducial marker visibility scoring · 5- Clearly visualized, unequivocal	5 Participants	—	—	—	—
Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel Fiducial marker visibility scoring · 1-Not visualized	0 Participants	—	—	—	—
Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel Fiducial marker visibility scoring · 2-Faint or trace visibility (shadow or haze)	0 Participants	—	—	—	—
Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel Fiducial marker visibility scoring · 3-Visibility but indistinct borders (definable entity)	0 Participants	—	—	—	—
Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel Fiducial marker visibility scoring · 4-Partially distinct border, partial haze	1 Participants	—	—	—	—
Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel TraceIT hydrogel visibility scoring · 1-Not visualized	0 Participants	—	—	—	—
Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel TraceIT hydrogel visibility scoring · 2-Faint or trace visibility (shadow or haze)	0 Participants	—	—	—	—
Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel TraceIT hydrogel visibility scoring · 3-Visibility but indistinct borders (definable entity)	2 Participants	—	—	—	—
Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel TraceIT hydrogel visibility scoring · 4-Partially distinct border, partial haze	0 Participants	—	—	—	—
Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel TraceIT hydrogel visibility scoring · 5- Clearly visualized, unequivocal	4 Participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-TraceIT and Post-TraceIT procedure, up to 2-6 weeks follow-up post radiation therapy

Population: Modified Intent to Treat (MITT)

The stability of TraceIT was measured as the minimum distance from the fiducial marker to TraceIT gel. Space measurements were taken before and after TraceIT was injected, which measured the preduodenal space using the axial view along the head of the HOP.

Outcome measures

Measure	All TIPS Participant n=6 Participants Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.	6 Month Follow-up Post Radiation Therapy n=3 Participants Number of subjects showing persistence and migration.	One or More Late (>3 Months) n=3 Participants Subjects who have experienced one or more AEs more than 3 months after index procedure.	12 Month Subject outcomes at 12 Month follow-up visit	18 Month Subject outcome at 18 month follow-up visit
TraceIT Stability and Space Measurements Stability - Minimum distance from fiducial to TraceIT gel (mm)	—	8.2 mm Standard Deviation 5.9	8.5 mm Standard Deviation 10.2	—	—
TraceIT Stability and Space Measurements TraceIT Space Measurement (mm)	1.0 mm Standard Deviation 0	7.7 mm Standard Deviation 2.4	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Changes from baseline final RT appointment, 3 months, 6 months, 12 months, and 18 months in QLQ-PAN26

Population: Modified Intent to Treat

The QLQ-PAN26 questionnaire is a survey designed to assess patient-reported symptoms of patients undergoing treatment for pancreatic cancer. All of the scales and single item measures range in score from 0-100. A high score for the symptom scales and/or single items represents a high level of symptomatology or problems, whereas a high score for the functional scales represents a high level of functioning.

Outcome measures

Measure	All TIPS Participant n=6 Participants Subjects with localized (resectable, borderline resectable or locally advanced) pancreatic cancer (defined per NCCN guidelines) that have completed induction chemotherapy if required and for whom a course of radiotherapy (RT) was indicated.	6 Month Follow-up Post Radiation Therapy n=6 Participants Number of subjects showing persistence and migration.	One or More Late (>3 Months) n=6 Participants Subjects who have experienced one or more AEs more than 3 months after index procedure.	12 Month n=4 Participants Subject outcomes at 12 Month follow-up visit	18 Month n=1 Participants Subject outcome at 18 month follow-up visit
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 Pancreatic Pain	1.7 score on a scale Interval -8.3 to 25.0	2.8 score on a scale Interval 0.0 to 8.3	-10 score on a scale Interval -25.0 to 0.0	8.3 score on a scale Interval 8.3 to 8.3	8.3 score on a scale Interval 8.3 to 8.3
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 Bloating	0 score on a scale Interval -33.3 to 33.3	11.1 score on a scale Interval 0.0 to 33.3	-6.7 score on a scale Interval -33.3 to 0.0	33.3 score on a scale Interval 33.3 to 33.3	0 score on a scale Interval 0.0 to 0.0
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 Digestive Symptoms	30 score on a scale Interval 0.0 to 50.0	44.4 score on a scale Interval 0.0 to 100.0	26.7 score on a scale Interval 0.0 to 66.7	-16.7 score on a scale Interval -16.7 to -16.7	66.7 score on a scale Interval 66.7 to 66.7
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 Taste	6.7 score on a scale Interval 0.0 to 33.3	66.7 score on a scale Interval 33.3 to 100.0	-6.7 score on a scale Interval -33.3 to 66.7	-33.3 score on a scale Interval -33.3 to -33.3	33.3 score on a scale Interval 33.3 to 33.3
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 Indigestion	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0	-26.7 score on a scale Interval -66.7 to 0.0	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 Flatulence	33.3 score on a scale Interval 0.0 to 66.7	0 score on a scale Interval -33.3 to 33.3	13.3 score on a scale Interval -33.3 to 66.7	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 Weight Loss	0 score on a scale Interval 0.0 to 0.0	11.1 score on a scale Interval 0.0 to 33.3	0 score on a scale Interval 0.0 to 0.0	33.3 score on a scale Interval 33.3 to 33.3	33.3 score on a scale Interval 33.3 to 33.3
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 Weakness arms and legs	0 score on a scale Interval -33.3 to 33.3	22.2 score on a scale Interval 0.0 to 33.3	13.3 score on a scale Interval 0.0 to 33.3	33.3 score on a scale Interval 33.3 to 33.3	33.3 score on a scale Interval 33.3 to 33.3
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 Dry Mouth	-6.7 score on a scale Interval -33.3 to 0.0	22.2 score on a scale Interval -33.3 to 100.0	-13.3 score on a scale Interval -33.3 to 0.0	33.3 score on a scale Interval 33.3 to 33.3	-33.3 score on a scale Interval -33.3 to -33.3
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 Hepatic Symptoms	-10 score on a scale Interval -33.3 to 0.0	-5.6 score on a scale Interval -16.7 to 0.0	-3.3 score on a scale Interval -16.7 to 0.0	50 score on a scale Interval 50.0 to 50.0	-16.7 score on a scale Interval -16.7 to -16.7
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 Altered Bowel Habit	-3.3 score on a scale Interval -83.3 to 66.7	22.2 score on a scale Interval 0.0 to 50.0	-3.3 score on a scale Interval -33.3 to 16.7	33.3 score on a scale Interval 33.3 to 33.3	16.7 score on a scale Interval 16.7 to 16.7
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 Body Image	0 score on a scale Interval -50.0 to 16.7	-11.1 score on a scale Interval -33.3 to 16.7	6.7 score on a scale Interval -50.0 to 83.3	0 score on a scale Interval 0.0 to 0.0	50 score on a scale Interval 50.0 to 50.0
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 Trouble with side-effects	-20 score on a scale Interval -66.7 to 33.3	22.2 score on a scale Interval 0.0 to 66.7	-6.7 score on a scale Interval -33.3 to 33.3	66.7 score on a scale Interval 66.7 to 66.7	33.3 score on a scale Interval 33.3 to 33.3
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 Future Worries	20 score on a scale Interval 0.0 to 66.7	-11.1 score on a scale Interval -33.3 to 0.0	0 score on a scale Interval -33.3 to 33.3	66.7 score on a scale Interval 66.7 to 66.7	33.3 score on a scale Interval 33.3 to 33.3
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 Planning of activities	-13.3 score on a scale Interval -100.0 to 33.3	44.4 score on a scale Interval 0.0 to 100.0	20 score on a scale Interval -33.3 to 66.7	0 score on a scale Interval 0.0 to 0.0	33.3 score on a scale Interval 33.3 to 33.3
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 Satisfaction with health care	6.7 score on a scale Interval -33.3 to 50.0	-5.6 score on a scale Interval -16.7 to 0.0	10 score on a scale Interval 0.0 to 33.3	0 score on a scale Interval 0.0 to 0.0	-16.7 score on a scale Interval -16.7 to -16.7
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 Sexuality	0 score on a scale Interval -33.3 to 33.3	0 score on a scale Interval -33.3 to 33.3	0 score on a scale Interval -33.3 to 50.0	-33.3 score on a scale Interval -33.3 to -33.3	0 score on a scale Interval 0.0 to 0.0

Adverse Events

TraceIT Tissue Spacer

Serious events: 6 serious events

Other events: 6 other events

Deaths: 3 deaths

Serious adverse events

Measure	TraceIT Tissue Spacer n=6 participants at risk TraceIT Tissue Spacer implantation: The TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care.
Gastrointestinal disorders Abdominal Pain	50.0% 3/6 • Number of events 6 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Hepatobiliary disorders Acute Cholangitis	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Renal and urinary disorders Acute Kidney Injury	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Gastrointestinal disorders Ascites	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Nervous system disorders Ataxia	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Hepatobiliary disorders Bile Duct Stenosis	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death due to Disease progression/worsening of Pancreatic Cancer	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Psychiatric disorders Delirium	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease recurrence in the pancreas and metastasis to the lower lobe of the right lung	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Nervous system disorders Dizziness	33.3% 2/6 • Number of events 2 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
General disorders Fever	33.3% 2/6 • Number of events 2 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Gastrointestinal disorders Gastrointestinal disorder- Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Gastrointestinal disorders Gastrointestinal disorders- Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Nervous system disorders Headache	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Nervous system disorders Hemorrhagic Stroke	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
General disorders High Fever	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Vascular disorders Hypertension	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Metabolism and nutrition disorders Hyponatremia	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Gastrointestinal disorders Ileus	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Infections and infestations Infections and infestations- Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Investigations Investigations - Other,	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder- Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other,	33.3% 2/6 • Number of events 2 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Nervous system disorders Nervous system disorders- Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Nervous system disorders Neuralgia	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
General disorders Non-cardiac chest pain	16.7% 1/6 • Number of events 2 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Hepatobiliary disorders Portal vein thrombosis	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Renal and urinary disorders Renal and urinary disorders - Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Respiratory, thoracic and mediastinal disorders Respiratory failure	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Respiratory, thoracic and mediastinal disorders Sleep apnea	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Surgical and medical procedures Surgical and medical procedures - Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Infections and infestations Urinary tract infection	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Ear and labyrinth disorders Vertigo	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.

Other adverse events

Measure	TraceIT Tissue Spacer n=6 participants at risk TraceIT Tissue Spacer implantation: The TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care.
Gastrointestinal disorders Abdominal distension	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Gastrointestinal disorders Abdominal pain	66.7% 4/6 • Number of events 10 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Investigations Alanine aminotransferase increased	33.3% 2/6 • Number of events 4 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Investigations Alkaline phosphatase increased	50.0% 3/6 • Number of events 4 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Skin and subcutaneous tissue disorders Alopecia	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Blood and lymphatic system disorders Anemia	83.3% 5/6 • Number of events 9 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Metabolism and nutrition disorders Anorexia	50.0% 3/6 • Number of events 5 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Psychiatric disorders Anxiety	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Respiratory, thoracic and mediastinal disorders Apnea	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Gastrointestinal disorders Ascites	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Investigations Aspartate aminotransferase increased	33.3% 2/6 • Number of events 4 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Respiratory, thoracic and mediastinal disorders Atelectasis	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Musculoskeletal and connective tissue disorders Back pain	33.3% 2/6 • Number of events 2 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Gastrointestinal disorders Bloating	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Injury, poisoning and procedural complications Bruising	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Cardiac disorders Cardiac disorders - Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
General disorders Chills	33.3% 2/6 • Number of events 2 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Gastrointestinal disorders Constipation	33.3% 2/6 • Number of events 3 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Investigations Decreased Leukocytes - Grade 2	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Investigations Decreased Neutrophils - Grade 2	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Investigations Decreased Platelet Count - Grade 1	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Metabolism and nutrition disorders Dehydration	50.0% 3/6 • Number of events 4 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Psychiatric disorders Depression	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Gastrointestinal disorders Diarrhea	66.7% 4/6 • Number of events 8 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
General disorders Disease Progression	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Nervous system disorders Dizziness	33.3% 2/6 • Number of events 2 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Gastrointestinal disorders Dry mouth	33.3% 2/6 • Number of events 2 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Skin and subcutaneous tissue disorders Dry skin	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Gastrointestinal disorders Dyspepsia	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Gastrointestinal disorders Dysphagia	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 3/6 • Number of events 3 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
General disorders Edema face	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
General disorders Edema limbs	33.3% 2/6 • Number of events 2 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
General disorders Erythmatous Injection Sites	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Eye disorders Eye pain	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
General disorders Fatigue	83.3% 5/6 • Number of events 9 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
General disorders Fever	66.7% 4/6 • Number of events 5 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Gastrointestinal disorders Flatulence	33.3% 2/6 • Number of events 2 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Gastrointestinal disorders Gastrointestinal disorders - Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
General disorders General disorders and administration site conditions - Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Nervous system disorders Headache	50.0% 3/6 • Number of events 5 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Vascular disorders Hematoma	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Renal and urinary disorders Hematuria	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Hepatobiliary disorders Hepatobiliary disorders - Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Vascular disorders Hot flashes	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Metabolism and nutrition disorders Hyperglycemia	33.3% 2/6 • Number of events 2 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Metabolism and nutrition disorders Hyperkalemia	16.7% 1/6 • Number of events 2 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Vascular disorders Hypertension	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 3/6 • Number of events 3 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Metabolism and nutrition disorders Hypocalcemia	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Metabolism and nutrition disorders Hypomagnesemia	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Metabolism and nutrition disorders Hyponatremia	33.3% 2/6 • Number of events 3 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Metabolism and nutrition disorders Hypophosphatemia	33.3% 2/6 • Number of events 2 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Gastrointestinal disorders Ileus	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Psychiatric disorders Insomnia	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Investigations Investigations - Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Musculoskeletal and connective tissue disorders Kyphosis	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Blood and lymphatic system disorders Leukocytosis	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
General disorders Localized edema	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Investigations Lymphocyte count decreased	50.0% 3/6 • Number of events 7 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
General disorders Malaise	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Nervous system disorders Memory impairment	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Infections and infestations Mild Chest Cold	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Gastrointestinal disorders Nausea	83.3% 5/6 • Number of events 15 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Nervous system disorders Nervous system disorders - Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Investigations Neutrophil count decreased	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
General disorders Non-cardiac chest pain	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Musculoskeletal and connective tissue disorders Occasional Leg Cramps	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Gastrointestinal disorders Occasional Nausea	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
General disorders Occasional Vomiting	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Infections and infestations Oral Thrush	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
General disorders Pain	33.3% 2/6 • Number of events 3 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Injury, poisoning and procedural complications Pain Near Incision Site	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Nervous system disorders Peripheral sensory neuropathy	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Investigations Platelet count decreased	33.3% 2/6 • Number of events 3 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Hepatobiliary disorders Portal vein thrombosis	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Renal and urinary disorders Proteinuria	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
General disorders Pruiritic Injection Sites	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Skin and subcutaneous tissue disorders Pruritus	33.3% 2/6 • Number of events 2 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Psychiatric disorders Psychiatric disorders - Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Skin and subcutaneous tissue disorders Rash acneiform	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Skin and subcutaneous tissue disorders Rash maculo-papular	16.7% 1/6 • Number of events 2 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Renal and urinary disorders Renal and urinary disorders - Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Cardiac disorders Sinus bradycardia	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Gastrointestinal disorders Stomach pain	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Vascular disorders Thromboembolic event	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Renal and urinary disorders Urinary frequency	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Renal and urinary disorders Urinary retention	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Vascular disorders Vascular disorders - Other	16.7% 1/6 • Number of events 1 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Investigations Weight loss	16.7% 1/6 • Number of events 2 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.
Injury, poisoning and procedural complications Wound dehiscence	16.7% 1/6 • Number of events 2 • Adverse events were recorded from initiation of fiducial marker placement through the 18 month visit. Adverse Events(AE), Adverse Device Effect (ADE),Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE), and Unanticipated Adverse Device Effect (UADE) were collected. All AEs and SAEs,will be collected from the time of fiducial maker placement and through the 18-month visit. Subjects who experience an AE/SAEs related to TraceIT hydrogel will be followed until the AE has resolved or until the subject has stabilized and FU care has been transferred to subject's primary care physician.

Additional Information

Jeya Satheesh

Boston Scientific

Phone: 6124490870

Email: jeya.satheesh@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place