POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy)
- Conditions
- Lung Neoplasms
- Interventions
- Device: Transbronchial Microwave Ablation
- Registration Number
- NCT05299606
- Lead Sponsor
- Ethicon, Inc.
- Brief Summary
This is a prospective, multicenter, single-arm study on transbronchial microwave ablation using the NEUWAVE FLEX Microwave Ablation System and Accessories on oligometastatic tumors in the peripheral lung, 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 primary endpoint is Technique Efficacy, assessed 30-days post-ablation via CT imaging.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Transbronchial Microwave Ablation Transbronchial Microwave Ablation Transbronchial microwave ablation will be performed using the NEUWAVE FLEX Microwave Ablation System and Accessories on oligometastatic tumors in the peripheral lung, 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.
- Primary Outcome Measures
Name Time Method Technique Efficacy 30 days (-7 to +14 days) post-ablation Ablation of the target tumor(s) with the ablation zone completely overlapping or encompassing the entire target tumor(s) using CT imaging.
- Secondary Outcome Measures
Name Time Method Local Tumor Progression 12-month visit Recurrence of the originally ablated target tumor(s) within or abutting the ablation zone using the 30-day post-ablation imaging as the baseline.
Repeat Ablation Efficacy Rate 12-month visit Rate of original tumors that have been re-ablated successfully (i.e., Technical Success of tumors that have been re-ablated out of all original tumors that have been re-ablated).
Local Tumor Progression Free Survival 12-month visit Time from the ablation until local tumor(s) progression or death, whichever occurs first.
Overall Survival 12-month visit Time from the original ablation until subject death (includes death from any cause).
Change in Pulmonary Function Tests (Spirometry II) 12-month visit Change in peak expiratory flow and maximum ventilation volume spirometry tests from pre-ablation baseline values to values at 3-months, 6-months, and 12-months post-ablation.
Peak Expiratory Flow is the maximal rate that one can exhale during a short maximal expiratory effort after a full inspiration and Maximum Ventilation Volume is the maximum minute volume of ventilation that one can maintain for 12-15 seconds. Both tests are expressed as L/min.Technical Success Immediately post-ablation (day 0) A complete tumor ablation with a surrounding minimal margin as assessed by cone beam CT imaging.
Navigational Success During navigation (day 0) Successful navigation to the targeted peripheral lung tumor(s) as confirmed using cone beam CT.
Progression Free Survival 12-month visit Time from the original ablation until tumor(s) progression or death, whichever occurs first (includes local, regional, or distant progression).
Change in Pulmonary Function Tests (Diffusion Capacity) 12-month visit Change in diffusion capacity from the pre-ablation baseline value to values at 3-months, 6-months, and 12-months post-ablation.
The diffusion capacity test measures the volume of carbon monoxide transferred from the lung to blood and is measured in ml/min/mmHg and put into a percentage (% of predicted).Disease (cancer) Specific Survival 12-month visit Time from the original ablation until death from the treated primary malignancy.
Change in Pulmonary Function Tests (Spirometry I) 12-month visit Change in all available (i.e., what is site standard-of-care) spirometry tests from pre-ablation baseline values to values at 3-months, 6-months, and 12-months post-ablation.
Spirometry tests are non-invasive and measure how much air one can breathe in and out of one's lungs, as well as how easily and fast one can the blow the air out of one's lungs. These tests include FVC (forced vital capacity, % of predicted), FEV1 (forced expiratory volume, % of predicted), FEV1/FVC (% ratio), and FEV 25-75 (average flow at which 25% has been exhaled through the point which 75% has been exhaled), all of which are expressed as a percentage.Change in EORTC QLQ-LC13 12-month visit Change in quality of life scores per the validated EORTC (European Organization for Research and Treatment of Cancer) QLQ-LC13 questionnaire from pre-ablation baseline scores to scores at 3-months, 6-months, and 12-months post-ablation. The questionnaire asks lung-cancer patients to choose a response that most closely describes them for 13 questions on a scale from 1-4 (1 being 'not at all', 2 being 'a little', 3 being 'quite a bit' and 4 being 'very much). The 13 questions are all about symptoms and problems experienced during the past week.
Change in Pulmonary Function Tests (Lung Volume) 12-month visit Change in lung volume from the pre-ablation baseline values to values at 3-months, 6-months, and 12-months post-ablation.
The lung volume tests include plethysmographic TLC (total lung capacity), plethysmographic FRC (functional residual capacity), plethysmographic RV (residual volume), gas dilution TLC, gas dilution FRC, and gas dilution RV. A plethysmograph measures changes in volume within an organ and a gas dilution test may determine lung volumes that cannot be determined from simple spirometry. All assessments are collected in liters (L) and put into a percentage (% of predicted).Change in EORTC QLQ-C30 12-month visit Change in quality of life scores per the validated EORTC (European Organization for Research and Treatment of Cancer) QLQ-C30 questionnaire from pre-ablation baseline scores to scores at 3-months, 6-months, and 12-months post-ablation. The questionnaire asks cancer patients to choose a response that most closely describes them for 30 questions on a scale from 1-4 (1 being 'not at all', 2 being 'a little', 3 being 'quite a bit' and 4 being 'very much). The 30 questions are separated into sections for 'general quality of life', 'during the past week', and 'overall health and quality of life'.
Trial Locations
- Locations (10)
Stanford University School of Medicine
🇺🇸Stanford, California, United States
UCONN Health
🇺🇸Farmington, Connecticut, United States
Minnesota Lung Center
🇺🇸Minneapolis, Minnesota, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
MD Anderson
🇺🇸Houston, Texas, United States
University of Toronto
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
FirstHealth Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Prince of Wales Hospital
ðŸ‡ðŸ‡°Sha Tin, Hong Kong