Trial Outcomes & Findings for POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy) (NCT NCT05299606)
NCT ID: NCT05299606
Last Updated: 2025-11-24
Results Overview
Technique Efficacy is defined as ablation of the target tumor(s) with the ablation zone completely overlapping or encompassing the entire target tumor(s) as assessed using CT imaging 30 days (- 7 to +14 days) after the ablation procedure.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
30 days post-ablation
Results posted on
2025-11-24
Participant Flow
Participant milestones
| Measure |
Transbronchial Microwave Ablation
Each participant underwent transbronchial microwave ablation to the target oligometastatic tumor(s) in the peripheral lung. The treating physician used the NEUWAVE FLEX Microwave Ablation System and Accessories, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone. The treating physician determined the ablation time and power used on a case-by-case basis.
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Transbronchial Microwave Ablation
Each participant underwent transbronchial microwave ablation to the target oligometastatic tumor(s) in the peripheral lung. The treating physician used the NEUWAVE FLEX Microwave Ablation System and Accessories, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone. The treating physician determined the ablation time and power used on a case-by-case basis.
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Overall Study
Death
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1
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Baseline Characteristics
POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy)
Baseline characteristics by cohort
| Measure |
Transbronchial Microwave Ablation
n=12 Participants
Each participant underwent transbronchial microwave ablation to the target oligometastatic tumor(s) in the peripheral lung. The treating physician used the NEUWAVE FLEX Microwave Ablation System and Accessories, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone. The treating physician determined the ablation time and power used on a case-by-case basis.
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Age, Continuous
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53.5 Years
STANDARD_DEVIATION 10.73 • n=45 Participants
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Sex: Female, Male
Female
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2 Participants
n=45 Participants
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Sex: Female, Male
Male
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10 Participants
n=45 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=45 Participants
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Race (NIH/OMB)
Asian
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3 Participants
n=45 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=45 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=45 Participants
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Race (NIH/OMB)
White
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6 Participants
n=45 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=45 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=45 Participants
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Smoking Status
Current Smoker
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2 Participants
n=45 Participants
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Smoking Status
Former Smoker
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7 Participants
n=45 Participants
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Smoking Status
Non-Smoker
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3 Participants
n=45 Participants
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Primary Cancer Diagnosis
Colorectal
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8 Participants
n=45 Participants
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Primary Cancer Diagnosis
Renal
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2 Participants
n=45 Participants
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Primary Cancer Diagnosis
Sarcoma
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2 Participants
n=45 Participants
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Stage at Time of Primary Cancer Diagnosis
Stage I
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3 Participants
n=45 Participants
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Stage at Time of Primary Cancer Diagnosis
Stage II
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2 Participants
n=45 Participants
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|
Stage at Time of Primary Cancer Diagnosis
Stage III
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6 Participants
n=45 Participants
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Stage at Time of Primary Cancer Diagnosis
Stage IV
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1 Participants
n=45 Participants
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PRIMARY outcome
Timeframe: 30 days post-ablationPopulation: Patients analyzed at 30 days post-ablation. 11 patients were analyzed as 1 patient passed away before the 30 day post-ablation visit.
Technique Efficacy is defined as ablation of the target tumor(s) with the ablation zone completely overlapping or encompassing the entire target tumor(s) as assessed using CT imaging 30 days (- 7 to +14 days) after the ablation procedure.
Outcome measures
| Measure |
Transbronchial Microwave Ablation
n=11 Participants
Each participant underwent transbronchial microwave ablation to the target oligometastatic tumor(s) in the peripheral lung. The treating physician used the NEUWAVE FLEX Microwave Ablation System and Accessories, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone. The treating physician determined the ablation time and power used on a case-by-case basis.
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Number of Patients Whose Ablation Resulted in Technique Efficacy
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11 Participants
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SECONDARY outcome
Timeframe: Immediately post-ablation (Day 0)Population: All treated patients
Technical Success is defined as ablation of the target lesion(s) according to the protocol and covered completely, with an adequate margin (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by the performing physician using CBCT imaging, immediately following the procedure.
Outcome measures
| Measure |
Transbronchial Microwave Ablation
n=12 Participants
Each participant underwent transbronchial microwave ablation to the target oligometastatic tumor(s) in the peripheral lung. The treating physician used the NEUWAVE FLEX Microwave Ablation System and Accessories, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone. The treating physician determined the ablation time and power used on a case-by-case basis.
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Number of Patients Whose Ablation Resulted in Technical Success
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12 Participants
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SECONDARY outcome
Timeframe: Assessed at 3 months, 6 months and 1 year post-ablationPopulation: Patients analyzed 30 days post-ablation through the 1 year follow up period. 11 patients were analyzed as 1 patient passed away before the 30 day post-ablation visit.
Local Tumor Progression, or recurrence of the originally ablated tumor(s) within or abutting the ablation zone, using the 30 day post-ablation imaging as baseline, was analyzed at 3 months, 6 months and 1 year post-ablation via CT imaging
Outcome measures
| Measure |
Transbronchial Microwave Ablation
n=11 Participants
Each participant underwent transbronchial microwave ablation to the target oligometastatic tumor(s) in the peripheral lung. The treating physician used the NEUWAVE FLEX Microwave Ablation System and Accessories, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone. The treating physician determined the ablation time and power used on a case-by-case basis.
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Number of Patients Who Experienced Local Tumor Progression
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11 Participants
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SECONDARY outcome
Timeframe: Assessed at 3 months, 6 months and 1 year post-ablationPopulation: Patients analyzed 30 days post-ablation through the 1 year follow up period. 11 patients were analyzed as 1 patient passed away before the 30 day post-ablation visit.
Disease Progression includes local tumor progression (that is, recurrence of the target ablated tumor within or abutting the ablation zone) and regional tumor progression (that is, new or progression of non-ablated pre-existing tumors within the lung but outside the ablation zone) and distant tumor progression. Results for each category (local, regional, and distant tumor progression) are specified, as well as Overall Disease Progression. Disease Progression was analyzed at 3 months, 6 months and 1 year post-ablation via CT imaging as per treating physician assessment
Outcome measures
| Measure |
Transbronchial Microwave Ablation
n=11 Participants
Each participant underwent transbronchial microwave ablation to the target oligometastatic tumor(s) in the peripheral lung. The treating physician used the NEUWAVE FLEX Microwave Ablation System and Accessories, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone. The treating physician determined the ablation time and power used on a case-by-case basis.
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Number of Patients Who Experienced Disease Progression
Overall Disease Progression
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3 Participants
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Number of Patients Who Experienced Disease Progression
Local Tumor Progression
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0 Participants
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Number of Patients Who Experienced Disease Progression
Regional Tumor Progression
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3 Participants
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Number of Patients Who Experienced Disease Progression
Distant Tumor Progression
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2 Participants
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SECONDARY outcome
Timeframe: Assessed at 3 months, 6 months and 1 year post-ablationPopulation: Patients analyzed 30 days post-ablation through the 1 year follow up period. 11 patients were analyzed as 1 patient passed away before the 30 day post-ablation visit.
Number of patients that experienced a recurrence of the successfully ablated target lesion, as assessed at Day 30 post-ablation, and underwent a repeat ablation of the target Lesion
Outcome measures
| Measure |
Transbronchial Microwave Ablation
n=11 Participants
Each participant underwent transbronchial microwave ablation to the target oligometastatic tumor(s) in the peripheral lung. The treating physician used the NEUWAVE FLEX Microwave Ablation System and Accessories, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone. The treating physician determined the ablation time and power used on a case-by-case basis.
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Number of Patients Who Required Repeat Ablation of Target Lesion
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0 Participants
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Adverse Events
Transbronchial Microwave Ablation
Serious events: 4 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Transbronchial Microwave Ablation
n=12 participants at risk
Each participant underwent transbronchial microwave ablation to the target oligometastatic tumor(s) in the peripheral lung. The treating physician used the NEUWAVE FLEX Microwave Ablation System and Accessories, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone. The treating physician determined the ablation time and power used on a case-by-case basis.
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Injury, poisoning and procedural complications
Post-ablation syndrome
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8.3%
1/12 • Number of events 1 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit from the time of consent through the end-of-study (1 year following the initial ablation procedure).
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Infections and infestations
Pneumonia
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8.3%
1/12 • Number of events 1 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit from the time of consent through the end-of-study (1 year following the initial ablation procedure).
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Hepatobiliary disorders
Jaundice cholestatic
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8.3%
1/12 • Number of events 1 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit from the time of consent through the end-of-study (1 year following the initial ablation procedure).
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General disorders
Pyrexia
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8.3%
1/12 • Number of events 1 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit from the time of consent through the end-of-study (1 year following the initial ablation procedure).
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Respiratory, thoracic and mediastinal disorders
Hemoptysis
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8.3%
1/12 • Number of events 2 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit from the time of consent through the end-of-study (1 year following the initial ablation procedure).
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Other adverse events
| Measure |
Transbronchial Microwave Ablation
n=12 participants at risk
Each participant underwent transbronchial microwave ablation to the target oligometastatic tumor(s) in the peripheral lung. The treating physician used the NEUWAVE FLEX Microwave Ablation System and Accessories, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone. The treating physician determined the ablation time and power used on a case-by-case basis.
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Injury, poisoning and procedural complications
Post-ablation syndrome
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33.3%
4/12 • Number of events 4 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit from the time of consent 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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16.7%
2/12 • Number of events 2 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit from the time of consent 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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16.7%
2/12 • Number of events 2 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit from the time of consent through the end-of-study (1 year following the initial ablation procedure).
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Respiratory, thoracic and mediastinal disorders
Hemoptysis
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8.3%
1/12 • Number of events 1 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit from the time of consent through the end-of-study (1 year following the initial ablation procedure).
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Respiratory, thoracic and mediastinal disorders
Pleural effusion
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8.3%
1/12 • Number of events 1 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit from the time of consent through the end-of-study (1 year following the initial ablation procedure).
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Respiratory, thoracic and mediastinal disorders
Pleuritic pain
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8.3%
1/12 • Number of events 1 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit from the time of consent through the end-of-study (1 year following the initial ablation procedure).
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Respiratory, thoracic and mediastinal disorders
Pneumothorax
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8.3%
1/12 • Number of events 1 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit from the time of consent through the end-of-study (1 year following the initial ablation procedure).
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Respiratory, thoracic and mediastinal disorders
Productive cough
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8.3%
1/12 • Number of events 1 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit from the time of consent through the end-of-study (1 year following the initial ablation procedure).
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Gastrointestinal disorders
Chest pain
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16.7%
2/12 • Number of events 3 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit from the time of consent through the end-of-study (1 year following the initial ablation procedure).
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Musculoskeletal and connective tissue disorders
Arthralgia
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16.7%
2/12 • Number of events 2 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit from the time of consent through the end-of-study (1 year following the initial ablation procedure).
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Musculoskeletal and connective tissue disorders
Pain in extremity
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8.3%
1/12 • Number of events 2 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit from the time of consent through the end-of-study (1 year following the initial ablation procedure).
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Gastrointestinal disorders
Diarrhea
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8.3%
1/12 • Number of events 1 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit from the time of consent through the end-of-study (1 year following the initial ablation procedure).
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Infections and infestations
Urinary Tract Infection
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8.3%
1/12 • Number of events 1 • 1 year following the initial ablation procedure.
Participants were evaluated for AEs and SAEs at every study visit from the time of consent 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