Trial Outcomes & Findings for NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung (NCT NCT03603652)
NCT ID: NCT03603652
Last Updated: 2020-12-21
Results Overview
Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CBCT imaging, immediately following the procedure.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Immediately post-ablation (day 0)
Results posted on
2020-12-21
Participant Flow
Participant milestones
| Measure |
Microwave Ablation
Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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8
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Microwave Ablation
Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
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|---|---|
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Overall Study
Death
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2
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Baseline Characteristics
NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung
Baseline characteristics by cohort
| Measure |
Microwave Ablation
n=10 Participants
Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
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|---|---|
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Age, Continuous
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69.3 Years
STANDARD_DEVIATION 7.689 • n=93 Participants
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Sex: Female, Male
Female
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6 Participants
n=93 Participants
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Sex: Female, Male
Male
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4 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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10 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=93 Participants
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Race (NIH/OMB)
White
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9 Participants
n=93 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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BMI
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26.8 kg/m^2
STANDARD_DEVIATION 4.469 • n=93 Participants
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Smoking Status
Current Smoker
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3 Participants
n=93 Participants
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Smoking Status
Former Smoker
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6 Participants
n=93 Participants
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Smoking Status
Non-Smoker
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1 Participants
n=93 Participants
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Radiation History
Yes, radiation history
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1 Participants
n=93 Participants
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Radiation History
No, radiation history
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9 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: Immediately post-ablation (day 0)Population: All treated patients.
Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CBCT imaging, immediately following the procedure.
Outcome measures
| Measure |
Microwave Ablation
n=10 Participants
Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
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|---|---|
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Number of Patients Whose Ablation Resulted in Technical Success
10
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10 Participants
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PRIMARY outcome
Timeframe: 30 days post-ablationPopulation: Patients analyzed at 30 days post-ablation.
Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CT imaging, 30 days (+/- 7 days) after the first ablation procedure.
Outcome measures
| Measure |
Microwave Ablation
n=9 Participants
Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
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|---|---|
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Number of Patients Whose Ablation Resulted in Technique Efficacy
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9 Participants
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PRIMARY outcome
Timeframe: Immediately post-ablationA Sponsor-created survey completed by the treating physician immediately post-ablation. Questions were all YES/NO.
Outcome measures
| Measure |
Microwave Ablation
n=10 Participants
Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
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|---|---|
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User Experience Survey (Part I)
Probe through channel as expected · YES
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10 Participants
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User Experience Survey (Part I)
Probe repositioned after first ablation · YES
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6 Participants
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User Experience Survey (Part I)
Ablation with NeuWave is predictable · YES
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10 Participants
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User Experience Survey (Part I)
Ablation with FLEX is simple to use · YES
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10 Participants
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User Experience Survey (Part I)
Success achieved similar to perc. · YES
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10 Participants
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User Experience Survey (Part I)
Locate probe/lesion with imaging · YES
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10 Participants
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User Experience Survey (Part I)
Locate ablation zone created · YES
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7 Participants
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PRIMARY outcome
Timeframe: Immediately post-ablationA Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the time it took to place the probe in a position that was ready for ablation.
Outcome measures
| Measure |
Microwave Ablation
n=10 Participants
Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
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|---|---|
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User Experience Survey (Part II)
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18.2 Minutes
Standard Deviation 11.25
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PRIMARY outcome
Timeframe: Immediately post-ablationA Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many cone-beam CT (CBCT) scans were taken to place the probe such that it was ready for ablation.
Outcome measures
| Measure |
Microwave Ablation
n=10 Participants
Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
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|---|---|
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User Experience Survey (Part III)
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4.4 Count of Scans
Standard Deviation 3.44
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PRIMARY outcome
Timeframe: Immediately post-ablationA Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the distance of the tip of the probe to the center of the soft-tissue lesion (in mm) just before the ablation procedure was initiated.
Outcome measures
| Measure |
Microwave Ablation
n=10 Participants
Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
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|---|---|
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User Experience Survey (Part IV)
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4.1 Millimeters
Standard Deviation 2.23
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PRIMARY outcome
Timeframe: Immediately post-ablationA Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many times the probe had to be repositioned to complete the ablation procedure.
Outcome measures
| Measure |
Microwave Ablation
n=10 Participants
Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
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|---|---|
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User Experience Survey (Part V)
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0.9 Count of Probe Repositions
Standard Deviation 0.93
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SECONDARY outcome
Timeframe: measured at 6 months and 1 year post-ablationPopulation: Only 9 patients were analyzed at 6 months post-ablation as 1 patient passed away before the 6 month study visit.
Analyzed at 6 months and 1 year post-ablation via CT imaging
Outcome measures
| Measure |
Microwave Ablation
n=9 Participants
Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
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|---|---|
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Number of Patients Who Experienced Target Lesion Recurrence
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0 Participants
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SECONDARY outcome
Timeframe: Within 30 days post-ablationAny readmission to the hospital within 30 days of the ablation procedure.
Outcome measures
| Measure |
Microwave Ablation
n=10 Participants
Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
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Number of Patients Who Were Readmitted to the Hospital
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1 Participants
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Adverse Events
Microwave Ablation
Serious events: 3 serious events
Other events: 9 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Microwave Ablation
n=10 participants at risk
Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
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|---|---|
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Nervous system disorders
Ataxia
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10.0%
1/10 • Number of events 1 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit starting with the ablation procedure through the end-of-study (1 year following the initial ablation procedure).
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Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
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10.0%
1/10 • Number of events 5 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit starting with the ablation procedure through the end-of-study (1 year following the initial ablation procedure).
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Infections and infestations
Infected Bite
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10.0%
1/10 • Number of events 1 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit starting with the ablation procedure through the end-of-study (1 year following the initial ablation procedure).
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Vascular disorders
Haemorrhage
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10.0%
1/10 • Number of events 1 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit starting with the ablation procedure through the end-of-study (1 year following the initial ablation procedure).
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Other adverse events
| Measure |
Microwave Ablation
n=10 participants at risk
Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.
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Respiratory, thoracic and mediastinal disorders
Hemoptysis
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60.0%
6/10 • Number of events 6 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit starting with the ablation procedure through the end-of-study (1 year following the initial ablation procedure).
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Respiratory, thoracic and mediastinal disorders
Cough
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40.0%
4/10 • Number of events 4 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit starting with the ablation procedure through the end-of-study (1 year following the initial ablation procedure).
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Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
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20.0%
2/10 • Number of events 9 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit starting with the ablation procedure through the end-of-study (1 year following the initial ablation procedure).
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Respiratory, thoracic and mediastinal disorders
Dyspnea
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20.0%
2/10 • Number of events 2 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit starting with the ablation procedure through the end-of-study (1 year following the initial ablation procedure).
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Gastrointestinal disorders
Nausea
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30.0%
3/10 • Number of events 4 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit starting with the ablation procedure through the end-of-study (1 year following the initial ablation procedure).
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Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
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30.0%
3/10 • Number of events 3 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit starting with the ablation procedure through the end-of-study (1 year following the initial ablation procedure).
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Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
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20.0%
2/10 • Number of events 2 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit starting with the ablation procedure through the end-of-study (1 year following the initial ablation procedure).
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General disorders
Fatigue
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30.0%
3/10 • Number of events 3 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit starting with the ablation procedure through the end-of-study (1 year following the initial ablation procedure).
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General disorders
Pyrexia
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20.0%
2/10 • Number of events 2 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit starting with the ablation procedure through the end-of-study (1 year following the initial ablation procedure).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60