POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy)

NCT05299606 | Terminated Results DMC FDA Device

• 1 other identifier: NEU_2020_03
• Study Type: interventional
• Target: 12
• Locations: 3 countries
• Sites: 10

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.

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

• Number of Patients Whose Ablation Resulted in Technique Efficacy

  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.

  30 days post-ablation

Secondary Outcomes (4)

• Number of Patients Whose Ablation Resulted in Technical Success

  Immediately post-ablation (Day 0)

• Number of Patients Who Experienced Local Tumor Progression

  Assessed at 3 months, 6 months and 1 year post-ablation

• Number of Patients Who Experienced Disease Progression

  Assessed at 3 months, 6 months and 1 year post-ablation

• Number of Patients Who Required Repeat Ablation of Target Lesion

  Assessed at 3 months, 6 months and 1 year post-ablation

Study Arms (1)

Transbronchial Microwave Ablation

EXPERIMENTAL

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.

Device: Transbronchial Microwave Ablation

Interventions

Transbronchial Microwave Ablation DEVICE

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.

Transbronchial Microwave Ablation

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Subjects greater or equal to 22 years old.
• Performance status 0-2 (Eastern Cooperative Oncology Group classification (ECOG).
• Willing to fulfill all follow-up visit requirements.
• Subjects with at least one oligometastatic lung tumor where the primary tumor is controlled (in the opinion of the investigator or treating oncologist).
• Oligometastatic lung tumor(s) planned to be ablated in the outer two-thirds of the lung and not closer than 1cm to the pleura.

You may not qualify if:

• Pregnant or breastfeeding.
• Subjects with thoracic implantable devices, including pacemakers or other electronic implants.
• Chronic, continuous ventilator support, which uses bi-level positive airway pressure (PAP) to improve lung function for severe conditions. (However, intermittent PAP, for non-pulmonary conditions, such as sleep apnea, is permitted).
• Prior pneumonectomy.
• Severe bronchiectasis (with FEV1 \<30%) or disease deemed to be too severe in the opinion of the investigator.
• Platelet count ≤ 50,000/mm3.
• Subjects with uncorrectable coagulopathy at time of screening.
• Subjects medically unable to stop anti-platelet agents (e.g., aspirin, clopidogrel, prasugrel, ticagrelor) at least 5 days prior to the procedure through 48-72 hours after the procedure.
• Subjects medically unable to stop warfarin at least 3-5 days prior to the ablation procedure, or until INR \< 1.5, through 48-72 hours after the procedure. On the day of the procedure, subjects with an INR \> 1.5 cannot have the procedure completed that day but may be rescheduled or postponed.
• Subjects medically unable to stop anticoagulants (e.g., rivaroxaban, apixaban, dabigatran, endoxaban) at least 3 days prior to the ablation procedure through 48-72 hours after the procedure.
• Expected survival less than 6 months in the opinion of the investigator and/or treating oncologist.
• Subjects with known or suspected brain metastases.
• Subject has had any radiation (i.e., SBRT or EBRT) to the intended ablation zone.
• Endobronchial tumors proximal to and including the segmental airways.
• Lung ablation, surgical resection therapy, radiotherapy, or any other treating procedure within 30 days prior to the planned study ablation procedure or those who plan to receive a lung ablation, surgical resection, or radiation therapy on the ablated lung side before completing the primary endpoint assessment (30 days post-ablation).

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (10)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

UCONN Health

Farmington, Connecticut, 06030, United States

Location

Minnesota Lung Center

Minneapolis, Minnesota, 55407, United States

Location

FirstHealth Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

University of Toronto

Toronto, Ontario, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Location

Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Erin Meyers
• Organization: ETHICON

eprifog1@its.jnj.com

937-681-0322

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 29, 2022
• Study Start: October 21, 2022
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: November 24, 2025
• Results First Posted: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

HK (1); US (7); CA (2)