Trial Outcomes & Findings for Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter (NCT NCT03569111)

NCT ID: NCT03569111

Last Updated: 2022-11-15

Results Overview

The primary endpoint is the rate of adverse events (AEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.

• Recruitment status: COMPLETED
• Target enrollment: 30 participants
• Primary outcome timeframe: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
• Results posted on: 2022-11-15

Participant Flow

Participant milestones

Measure	NAVABLATE (Single-arm Study) Observational NAVABLATE arm (single-arm, no comparator)
Overall Study STARTED	30
Overall Study Procedure	30
Overall Study 1-Month	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter

Baseline characteristics by cohort

Measure	NAVABLATE (Single-arm Study) n=30 Lesions Observational NAVABLATE arm (single-arm study, no comparator)
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=30 Participants
Age, Categorical >=65 years	19 Participants n=30 Participants
Age, Continuous	68.4 Years STANDARD_DEVIATION 10.3 • n=30 Participants
Sex: Female, Male Female	12 Participants n=30 Participants
Sex: Female, Male Male	18 Participants n=30 Participants
Region of Enrollment Hong Kong	14 Participants n=30 Participants
Region of Enrollment United Kingdom	16 Participants n=30 Participants
Chronic obstructive pulmonary disease	10 Participants n=30 Participants
Tobacco use (current or former)	20 Participants n=30 Participants
Prior lung procedures performed Lung surgery	11 Participants n=30 Participants
Prior lung procedures performed Radiotherapy	1 Participants n=30 Participants
Prior lung procedures performed Non-surgical biopsy procedure	19 Participants n=30 Participants
No prior lung procedure performed	7 Participants n=30 Participants
Eligibility for Lung surgery or SBRT Not a candidate for lung surgery or Stereotactic body radiation therapy (SBRT)	14 Participants n=30 Participants
Eligibility for Lung surgery or SBRT Declined both lung surgery and SBRT	10 Participants n=30 Participants
Eligibility for Lung surgery or SBRT Not a candidate for lung surgery and declined SBRT	5 Participants n=30 Participants
Eligibility for Lung surgery or SBRT Not a candidate for SBRT and declined lung surgery	1 Participants n=30 Participants
State of cancer diagnosis Primary Lung Cancer	20 Participants n=30 Participants
State of cancer diagnosis Oligometastatic	10 Participants n=30 Participants
Nodule size (mm)	13.7 millimeters STANDARD_DEVIATION 5.3 • n=30 Lesions
Lobe zone of nodule Peripheral third of lung	19 Lesions n=30 Lesions
Lobe zone of nodule Middle third of lung	11 Lesions n=30 Lesions
Lobe zone of nodule Proximal third of lung	0 Lesions n=30 Lesions
Lobe location Right Upper Lobe	10 Participants n=30 Participants
Lobe location Right Middle Lobe	2 Participants n=30 Participants
Lobe location Right Lower Lobe	8 Participants n=30 Participants
Lobe location Left Upper Lobe	6 Participants n=30 Participants
Lobe location Left Lower Lobe	4 Participants n=30 Participants
Bronchus sign present	14 Participants n=30 Participants
Lesion morphology Suzuki class 1 or 2 (Pure Ground Glass Opacity [GGO] or Mostly GGO)	3 Lesions n=30 Lesions
Lesion morphology Suzuki class 3 or 4 (Halo or Mixed)	5 Lesions n=30 Lesions
Lesion morphology Suzuki class 5 or 6 (Solid Pattern with GGO or Solid)	22 Lesions n=30 Lesions

PRIMARY outcome

Timeframe: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)

Population: The number of participants analyzed includes subjects who were available at that time of analysis.

The primary endpoint is the rate of adverse events (AEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.

Outcome measures

Measure	NAVABLATE (Single-Arm Study) n=30 Participants Observational NAVABLATE arm (single-arm, no comparator)
Number of Participants With AEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology	1 Participants

SECONDARY outcome

Timeframe: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Rate of serious AEs (SAEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.

Outcome measures

Measure	NAVABLATE (Single-Arm Study) n=30 Participants Observational NAVABLATE arm (single-arm, no comparator)
Number of Participants With SAEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology	0 Participants

SECONDARY outcome

Timeframe: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Rate of all AEs related to the procedure or study devices through 1-month follow-up.

Rate of all AEs related to the procedure or study devices through 1-month follow-up was also measured based on Common Terminology Criteria for Adverse Events (CTCAE) classification. CTCAE grading is evaluated on a scale from 1-5 (1 - mild; intervention not indicated; 5 - most severe; death related to AE). Subjects could have more than one AE with different CTCAE Grades.

Outcome measures

Measure	NAVABLATE (Single-Arm Study) n=30 Participants Observational NAVABLATE arm (single-arm, no comparator)
Number of Participants With AEs Related to Study Procedure or Study Devices CTCAE Grade 2	11 Participants
Number of Participants With AEs Related to Study Procedure or Study Devices CTCAE Grade 4	0 Participants
Number of Participants With AEs Related to Study Procedure or Study Devices Composite rate of all AEs related to the procedure or study devices	21 Participants
Number of Participants With AEs Related to Study Procedure or Study Devices CTCAE Grade 1	15 Participants
Number of Participants With AEs Related to Study Procedure or Study Devices CTCAE Grade 3	4 Participants
Number of Participants With AEs Related to Study Procedure or Study Devices CTCAE Grade 5	0 Participants

SECONDARY outcome

Timeframe: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Rate of all SAEs related to the procedure or study devices through 1-month follow-up.

Outcome measures

Measure	NAVABLATE (Single-Arm Study) n=30 Participants Observational NAVABLATE arm (single-arm, no comparator)
Number of Participants With SAEs Related to the Study Procedure or Study Devices	4 Participants

SECONDARY outcome

Timeframe: Immediately following the procedure, 1 week post-procedure, 1-month post-procedure; all were collected at the 1-month follow-up visit (20-40 days post-procedure)

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Patient satisfaction, pain, and breathlessness (Bronchoscopic Ablation Patient Pain and Satisfaction Survey)

At the 1-month visit, subjects assessed their pain/discomfort and breathlessness based on how they recall feeling at 3 different timepoints. The timepoints were immediately, one week, and one month after the bronchoscopic ablation procedure. Pain or discomfort were evaluated on a scale from 0-10 (10 - severe/interferes with basic needs). Breathlessness was evaluated on a scale from 1-5 (5 - too breathless to leave the house, or breathless when undressing).

Subjects also evaluated their willingness to have the procedure performed again on a scale from 1-5 (5 - extremely likely), how likely they would recommend the procedure to family and friends on a scale from 1-5 (5 - extremely likely), and how satisfied they were with the procedure on a scale from 1-5 (5 - extremely satisfied).

Outcome measures

Measure	NAVABLATE (Single-Arm Study) n=30 Participants Observational NAVABLATE arm (single-arm, no comparator)
Score of Patient Satisfaction, Pain, and Breathlessness Pain/discomfort immediately after procedure	1.5 score on a scale Standard Deviation 2.2
Score of Patient Satisfaction, Pain, and Breathlessness Pain/discomfort one week after procedure	1.4 score on a scale Standard Deviation 1.8
Score of Patient Satisfaction, Pain, and Breathlessness Pain/discomfort one month after procedure	0.5 score on a scale Standard Deviation 1.1
Score of Patient Satisfaction, Pain, and Breathlessness Breathlessness immediately after procedure	1.8 score on a scale Standard Deviation 1.0
Score of Patient Satisfaction, Pain, and Breathlessness Breathlessness one week after procedure	1.6 score on a scale Standard Deviation 1.0
Score of Patient Satisfaction, Pain, and Breathlessness Breathlessness one month after procedure	1.5 score on a scale Standard Deviation 0.9
Score of Patient Satisfaction, Pain, and Breathlessness Willingness to have the procedure performed again	4.8 score on a scale Standard Deviation 0.8
Score of Patient Satisfaction, Pain, and Breathlessness Likelihood to recommend the procedure to family and friends	4.9 score on a scale Standard Deviation 0.4
Score of Patient Satisfaction, Pain, and Breathlessness Satisfaction with procedure at 1-month	4.8 score on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: Baseline and 1-month

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Quality of life evaluation based on EuroQol [EQ-5D-3L] survey. The questions from the survey surround current health status. The subjects assessed their current health state on a scale of 0-100 (100 being the best health state imaginable).

Outcome measures

Measure	NAVABLATE (Single-Arm Study) n=30 Participants Observational NAVABLATE arm (single-arm, no comparator)
Score of Current Health State From Quality of Life Survey 1-month	77.4 score on a scale Standard Deviation 14.2
Score of Current Health State From Quality of Life Survey Baseline	74.6 score on a scale Standard Deviation 12.8

SECONDARY outcome

Timeframe: Immediately post-procedure

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Technical success: An evaluation of whether the lung nodule was treated according to the study protocol as determined at the immediate post-procedural timepoint. This is in contrast to procedures in which the protocol could not be executed completely, either for technical reasons or for reasons related to comorbid disease.

Outcome measures

Measure	NAVABLATE (Single-Arm Study) n=30 lesions ablated Observational NAVABLATE arm (single-arm, no comparator)
Number of Lung Nodules Evaluated as Being Treated According to the Study Protocol	30 lesions ablated

SECONDARY outcome

Timeframe: 1-month follow-up (an average of 20-40 days post-procedure)

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Technique efficacy: An evaluation of whether the lung nodule was effectively ablated. Evaluates whether complete ablation of the nodule was achieved as evidenced by CT imaging follow-up 1-month post-procedure (including a window of 20-40 days post-procedure).

Outcome measures

Measure	NAVABLATE (Single-Arm Study) n=30 lesions ablated Observational NAVABLATE arm (single-arm, no comparator)
Number of Lung Nodules Evaluated as Being Effectively Ablated	30 lesions ablated

Adverse Events

NAVABLATE (Single-arm Study)

Serious events: 4 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	NAVABLATE (Single-arm Study) n=30 participants at risk Observational NAVABLATE arm (single-arm study, no comparator)
Infections and infestations Administration site infection	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.
Injury, poisoning and procedural complications Post ablation syndrome	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.
Injury, poisoning and procedural complications Post procedural inflammation	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.
Injury, poisoning and procedural complications Procedural pain	6.7% 2/30 • Number of events 2 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.
Respiratory, thoracic and mediastinal disorders Haemoptysis	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.7% 2/30 • Number of events 2 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.

Other adverse events

Measure	NAVABLATE (Single-arm Study) n=30 participants at risk Observational NAVABLATE arm (single-arm study, no comparator)
Cardiac disorders Bradycardia	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.
General disorders Chest discomfort	6.7% 2/30 • Number of events 2 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.
Infections and infestations Lower respiratory tract infection	6.7% 2/30 • Number of events 2 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.
Injury, poisoning and procedural complications Post ablation syndrome	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.
Injury, poisoning and procedural complications Procedural pain	43.3% 13/30 • Number of events 15 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.
Injury, poisoning and procedural complications Unwanted awareness during anaesthesia	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.
Respiratory, thoracic and mediastinal disorders Cough	6.7% 2/30 • Number of events 2 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	23.3% 7/30 • Number of events 7 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.
Respiratory, thoracic and mediastinal disorders Haemoptysis	16.7% 5/30 • Number of events 5 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.0% 3/30 • Number of events 3 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.7% 2/30 • Number of events 2 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.
Respiratory, thoracic and mediastinal disorders Pleural thickening	3.3% 1/30 • Number of events 1 • Adverse event data was collected from the point of enrollment (when the Emprint catheter was inserted into the compatible extended working channel) up to 1-month post-procedure. Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.

Additional Information

Julie Krzykowski

Medtronic

Phone: 763-202-3325

Email: Julie.Krzykowski@Medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee Institution/Investigator shall not publish the Study results until after Sponsor's multi-site publication and final study results are complete or until the elapse of twelve (12) months from the close of the Study at all Study sites, whichever occurs first; unless approved by Sponsor.
• Publication restrictions are in place

Restriction type: OTHER