Last reviewed · How we verify
POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy)
NA trial testing Transbronchial Microwave Ablation in Lung Neoplasms in 12 participants. Terminated before completion.
| Lead sponsor | Ethicon, Inc. |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 21 October 2022 |
| Primary completion | 18 October 2024 |
| Estimated completion | 18 October 2024 |
| Sites | 10 locations across Hong Kong, Canada, United States |
Ethicon, Inc. — full company profile →
22 and older, any sex, with Lung Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Transbronchial Microwave Ablation | 11 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Transbronchial Microwave Ablation | 12 |
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
| Group | Value | 95% CI |
|---|---|---|
| Transbronchial Microwave Ablation | 11 |
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
| Group | Value | 95% CI |
|---|---|---|
| Transbronchial Microwave Ablation | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Transbronchial Microwave Ablation | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Transbronchial Microwave Ablation | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Transbronchial Microwave Ablation | 2 |
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
| Group | Value | 95% CI |
|---|---|---|
| Transbronchial Microwave Ablation | 0 |
Time frame: 1 year following the initial ablation procedure.. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Transbronchial Microwave A… |
|---|---|---|
| Post-ablation syndrome | Injury, poisoning and procedural complications | — |
| Pneumonia | Infections and infestations | — |
| Jaundice cholestatic | Hepatobiliary disorders | — |
| Pyrexia | General disorders | — |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Transbronchial Microwave A… |
|---|---|---|
| Post-ablation syndrome | Injury, poisoning and procedural complications | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Chest pain | Gastrointestinal disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — |
| Productive cough | Respiratory, thoracic and mediastinal disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Urinary Tract Infection | Infections and infestations | — |
Most-reported serious reactions: Post-ablation syndrome, Pneumonia, Jaundice cholestatic, Pyrexia, Hemoptysis.
Data from ClinicalTrials.gov NCT05299606 adverse events section.
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.
5 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05299606.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing