Trial Outcomes & Findings for A Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems (SPY-PHI) in the Visualization of Lymphatic Vessels and Identification of Lymph Nodes During Sentinel Lymph Node Biopsy in Subjects With Breast Cancer (NCT NCT03200704)
NCT ID: NCT03200704
Last Updated: 2023-09-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
152 participants
Primary outcome timeframe
From Technetium-99 (Tc-99m) injection to the completion of surgery
Results posted on
2023-09-21
Participant Flow
Subjects assessed for eligibility (n=153)
Participant milestones
| Measure |
IC2000/SPY-PHI
Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.
IC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
Tc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
|
|---|---|
|
Overall Study
STARTED
|
152
|
|
Overall Study
COMPLETED
|
151
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
IC2000/SPY-PHI
Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.
IC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
Tc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
\*PP/ mITT population (N=148)
Baseline characteristics by cohort
| Measure |
IC2000/SPY-PHI
n=152 Participants
Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.
IC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
Tc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
|
|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 11.50 • n=148 Participants • \*PP/ mITT population (N=148)
|
|
Sex: Female, Male
Female
|
148 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
|
Sex: Female, Male
Male
|
0 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
|
Race/Ethnicity, Customized
White
|
120 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
|
Race/Ethnicity, Customized
Black or African
|
11 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
|
Race/Ethnicity, Customized
Hispanic
|
5 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
|
Region of Enrollment
Canada
|
49 participants
n=152 Participants • \*Please note, the region of enrollment total reflects total subjects enrolled (N=152)
|
|
Region of Enrollment
United States
|
103 participants
n=152 Participants • \*Please note, the region of enrollment total reflects total subjects enrolled (N=152)
|
|
Smoker, n (%)
Current
|
10 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
|
Smoker, n (%)
Past
|
40 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
|
Smoker, n (%)
Never
|
98 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
|
Alcohol consumption, n (%)
Yes
|
75 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
|
Alcohol consumption, n (%)
No
|
73 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
|
Comorbid conditions of interest, n (%)
Hypertension
|
54 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
|
Comorbid conditions of interest, n (%)
Cardiac Disease
|
9 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
|
Comorbid conditions of interest, n (%)
COPD
|
4 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
|
Comorbid conditions of interest, n (%)
Diabetes
|
17 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
|
Comorbid conditions of interest, n (%)
Renal Failure
|
2 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
|
Comorbid conditions of interest, n (%)
Liver Disease
|
1 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
|
Comorbid conditions of interest, n (%)
Other
|
61 Participants
n=148 Participants • \*PP/ mITT population (N=148)
|
PRIMARY outcome
Timeframe: From Technetium-99 (Tc-99m) injection to the completion of surgeryPopulation: PP and mITT populations
Outcome measures
| Measure |
IC2000/SPY-PHI
n=406 Lymph Nodes
Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.
IC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
Tc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
|
|---|---|
|
Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe
Proportion of histology confirmed lymph nodes identified using IC2000 and SPY
|
360 Lymph Nodes
|
|
Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe
Proportion of histology confirmed lymph nodes identified using Tc-99m/Gamma Probe
|
266 Lymph Nodes
|
SECONDARY outcome
Timeframe: From Technetium-99 (Tc-99m) injection to the completion of surgeryPopulation: PP and mITT population \*The PP and mITT populations were identical
Outcome measures
| Measure |
IC2000/SPY-PHI
n=148 Participants
Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.
IC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
Tc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
|
|---|---|
|
Proportion of Subjects With at Least One Lymph Node Identified by IC2000/SPY-PHI, and the Proportion of Subjects With at Least One Lymph Node Identified by Tc99m/Gamma Probe
Proportion of Subjects with At Least One Lymph Node Identified by IC2000 and SPY in-vivo
|
145 Participants
|
|
Proportion of Subjects With at Least One Lymph Node Identified by IC2000/SPY-PHI, and the Proportion of Subjects With at Least One Lymph Node Identified by Tc99m/Gamma Probe
Proportion of Subjects with At Least One Lymph Node Identified by Tc-99m/Gamma Probe
|
145 Participants
|
SECONDARY outcome
Timeframe: From Technetium-99 (Tc-99m) injection to the completion of surgeryPopulation: Total number of histology confirmed clinical lymph nodes (specimens) identified and excised by IC2000 and SPY. \*The PP and mITT populations were identical
Outcome measures
| Measure |
IC2000/SPY-PHI
n=360 Lymph Nodes
Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.
IC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
Tc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
|
|---|---|
|
Proportion of Lymph Nodes Identified by IC2000/SPY-PHI by Following a Fluorescent Lymphatic Vessel, and the Proportion of Identified Lymph Nodes With no Lymphatic Vessels Visible by IC2000/SPY-PHI
Proportion of Lymph Nodes Identified by IC2000 and SPY in-vivo With Lymphatic Vessel Mapping
|
357 Lymph Nodes
|
|
Proportion of Lymph Nodes Identified by IC2000/SPY-PHI by Following a Fluorescent Lymphatic Vessel, and the Proportion of Identified Lymph Nodes With no Lymphatic Vessels Visible by IC2000/SPY-PHI
Proportion of Lymph Nodes Identified by IC2000 and SPY in-vivo Without Lymphatic Vessel Mapping
|
3 Lymph Nodes
|
SECONDARY outcome
Timeframe: From Technetium-99 (Tc-99m) injection to the completion of surgeryPopulation: Safety cohort (N=151)
Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0
Outcome measures
| Measure |
IC2000/SPY-PHI
n=151 Participants
Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.
IC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
Tc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
|
|---|---|
|
To Assess the Safety of Intradermal Injection of IC2000
|
3 Participants
|
Adverse Events
IC2000/SPY-PHI
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IC2000/SPY-PHI
n=151 participants at risk
Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.
IC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
Tc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.66%
1/151 • Number of events 2 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Investigations
Oxygen saturation decreased
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
100.0%
1/1 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Vascular disorders
Hypertension
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
Other adverse events
| Measure |
IC2000/SPY-PHI
n=151 participants at risk
Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.
IC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
Tc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.66%
1/151 • Number of events 2 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Cardiac disorders
Angina Pectoris
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.3%
2/151 • Number of events 2 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Endocrine disorders
Goitre
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Gastrointestinal disorders
Vomiting
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
General disorders
Fatigue
|
1.3%
2/151 • Number of events 2 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
General disorders
Injection site discoloration
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Infections and infestations
Wound Infection
|
2.6%
4/151 • Number of events 4 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Injury, poisoning and procedural complications
Seroma
|
2.6%
4/151 • Number of events 4 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Injury, poisoning and procedural complications
Skin Flap Necrosis
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Investigations
Oxygen Saturation Decreased
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Hematoma
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Product Issues
Device Occlusion
|
1.3%
2/151 • Number of events 2 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Skin and subcutaneous tissue disorders
Ischemic Skin Ulcer
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Skin and subcutaneous tissue disorders
Skin Discoloration
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Skin and subcutaneous tissue disorders
Skin Necrosis
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Vascular disorders
Flushing
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
|
Vascular disorders
Hypertension
|
0.66%
1/151 • Number of events 1 • Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
|
Additional Information
Colleen Roden, Director of Clinical Sciences and Operations
Novadaq Technologies ULC, now a part of Stryker
Phone: 931-267-2041
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60