Lung NeoplasmsNCT05299606
POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy)
A study testing Transbronchial Microwave Ablation in people with Lung Neoplasms, run by Ethicon, Inc. at 10 sites in 3 countries.
Trial 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)… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Transbronchial Microwave Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 21 Oct 2022to 18 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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).
- Systemic therapy (e.g., chemotherapy, targeted drug therapy, or immunotherapy) within 14 days prior to the planned study ablation procedure or those who plan to receive systemic therapy before completing the primary endpoint assessment (30 days post-ablation).
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States7 sites
Cleveland Clinic
Cleveland, Ohio, 44195
UCONN Health
Farmington, Connecticut, 06030
MD Anderson
Houston, Texas, 77030
Minnesota Lung Center
Minneapolis, Minnesota, 55407
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
Stanford University School of Medicine
Stanford, California, 94305
Canada2 sites
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec
University of Toronto
Toronto, Ontario
About this study
Official title: A Prospective Multicenter Study of Transbronchial Microwave Ablation Using Robotic-Assisted Bronchoscopy in Subjects With Oligometastatic Tumors in the Lung
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
- Being tested
- Transbronchial Microwave Ablation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transbronchial Microwave AblationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transbronchial Microwave Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post-ablation
Secondary outcomes (4)
Number of Patients Whose Ablation Resulted in Technical Success
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.
Measured: Immediately post-ablation (Day 0)
Number of Patients Who Experienced Local Tumor Progression
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
Measured: Assessed at 3 months, 6 months and 1 year post-ablation
Number of Patients Who Experienced Disease Progression
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
Measured: Assessed at 3 months, 6 months and 1 year post-ablation
Number of Patients Who Required Repeat Ablation of Target Lesion
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
Measured: Assessed at 3 months, 6 months and 1 year post-ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start21 Oct 2022
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
Why it stopped: Change in Sponsor strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299606
- Sponsor's protocol ID
- NEU_2020_03
- Status last verified
- Nov 2025
- First submitted
- 3 Mar 2022
- Last updated
- 24 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study of Transbronchial Microwave Ablation Using Robotic-Assisted Bronchoscopy in Subjects With Oligometastatic Tumors in the Lung
- ClinicalTrials.gov ID
- NCT05299606
- Acronym / sponsor ID
- NEU_2020_03
- Conditions
- Lung Neoplasms
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in Sponsor strategy
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Posted 24 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transbronchial Microwave Ablation | Experimental | Device: Transbronchial Microwave AblationTransbronchial 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transbronchial Microwave AblationTransbronchial 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 |
Primary outcome
Number of Patients Whose Ablation Resulted in Technique Efficacy
Time frame: 30 days post-ablation
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.
4 secondary outcomes
Number of Patients Whose Ablation Resulted in Technical Success
Time frame: Immediately post-ablation (Day 0)
Number of Patients Who Experienced Local Tumor Progression
Time frame: Assessed at 3 months, 6 months and 1 year post-ablation
Number of Patients Who Experienced Disease Progression
Time frame: Assessed at 3 months, 6 months and 1 year post-ablation
Number of Patients Who Required Repeat Ablation of Target Lesion
Time frame: Assessed at 3 months, 6 months and 1 year post-ablation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transbronchial Microwave Ablation in people with Lung Neoplasms, run by Ethicon, Inc. at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Whose Ablation Resulted in Technique Efficacy (time frame: 30 days post-ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.