Trial Outcomes & Findings for Microwave Ablation in Chinese Patients With Lung Tumors (NCT NCT04889989)

Results Overview

Percentage of tumors that were completely covered by the ablation zone with no sign of pathological enhancement according to the lung contrast-enhanced CT assessment as assessed by the Independent Review Committee.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

30 days (+/- 7 days) post-ablation

Results posted on

2026-02-04

Participant Flow

Chinese adult patients with NSCLC (non-small cell lung cancer) or oligometastatic lung tumors (2cm or less in size) who were candidates for percutaneous microwave ablation were considered for the study. Patients were given the Informed Consent Form to read, ask questions, and sign prior to any study procedures being performed or data being collected.

As a single-arm study, all patients enrolled received the same treatment: microwave ablation using the NEUWAVE Microwave Ablation System and Probes. The first 2 patients at each treating site (2 patients at 2 sites = 4 total patients) were part of the 'run-in' cohort. The Run-In cohort was implemented to reduce operational bias due to the learning curve. Run-In patients were included in the safety analysis set only.

Unit of analysis: Tumors

Participant milestones

Participant milestones
Measure	Microwave Ablation Lung tumors treated with microwave ablation (includes the run-in patients) and still alive at the end of the study (1-year post-ablation)
Overall Study STARTED	13 14
Overall Study Run-In	4 4
Overall Study Withdrew Consent	1 1
Overall Study Died	1 1
Overall Study Lost to Follow-Up	1 2
Overall Study COMPLETED	6 6
Overall Study NOT COMPLETED	7 8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Microwave Ablation in Chinese Patients With Lung Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Microwave Ablation n=10 Tumors Lung tumors treated with microwave ablation (includes the run-in patients) and still alive at the end of the study (1-year post-ablation)
Age, Continuous	54.0 Years n=25 Participants
Sex: Female, Male Female	6 Participants n=25 Participants
Sex: Female, Male Male	3 Participants n=25 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants
Race (NIH/OMB) Asian	9 Participants n=25 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants
Race (NIH/OMB) Black or African American	0 Participants n=25 Participants
Race (NIH/OMB) White	0 Participants n=25 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants

PRIMARY outcome

Timeframe: 30 days (+/- 7 days) post-ablation

Percentage of tumors that were completely covered by the ablation zone with no sign of pathological enhancement according to the lung contrast-enhanced CT assessment as assessed by the Independent Review Committee.

Outcome measures

Outcome measures
Measure	Microwave Ablation n=9 Tumors Lung tumors treated with microwave ablation (does not include the run-in patients)
Technical Efficacy Rate	8 Tumors

SECONDARY outcome

Timeframe: Ablation Day (day 0)

Percentage of tumors that achieve A0 or A1 ablation classification determinations (i.e., complete tumor ablation with a surrounding margin) based on the lung CT immediately following the initial ablation procedure and as assessed by the Independent Review Committee.

Outcome measures

Outcome measures
Measure	Microwave Ablation n=9 Tumors Lung tumors treated with microwave ablation (does not include the run-in patients)
Technical Success Rate	9 Tumors

SECONDARY outcome

Timeframe: 1 year post-ablation

Progression of disease to a tumor treated during the original microwave ablation procedure.

Outcome measures

Outcome measures
Measure	Microwave Ablation n=8 Tumors Lung tumors treated with microwave ablation (does not include the run-in patients)
Local Tumor Progression	1 Tumors

SECONDARY outcome

Timeframe: 1-year post-ablation

Rate of patients still alive 1-year post-ablation (includes lead-in participants so out of 13).

Outcome measures

Outcome measures
Measure	Microwave Ablation n=13 Participants Lung tumors treated with microwave ablation (does not include the run-in patients)
Overall Survival	12 Participants

SECONDARY outcome

Timeframe: 1-year post-ablation

Rate of patients still alive 1-year post-ablation without any sort of progression of disease (local, regional, or distant).

Outcome measures

Outcome measures
Measure	Microwave Ablation n=12 Participants Lung tumors treated with microwave ablation (does not include the run-in patients)
Progression-Free Survival	10 Participants

Adverse Events

All Patients Treated With Microwave Ablation

Serious events: 2 serious events

Other events: 10 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	All Patients Treated With Microwave Ablation n=13 participants at risk Includes all patients treated with microwave ablation (including run-in patients)
Cardiac disorders Myocardial Infarction	7.7% 1/13 • Number of events 1 • 1-year post-ablation From the time of the ablation procedure through 30 days post-ablation, all AEs and serious AEs (SAEs) were recorded. After 30 days post-ablation, only AEs judged by the PI as related to the study device and/or procedure and all SAEs were reported. AEs/SAEs summarized below include all events reported and do not distinguish between being device- or procedure-related.
Nervous system disorders Cerebral Infarction	7.7% 1/13 • Number of events 1 • 1-year post-ablation From the time of the ablation procedure through 30 days post-ablation, all AEs and serious AEs (SAEs) were recorded. After 30 days post-ablation, only AEs judged by the PI as related to the study device and/or procedure and all SAEs were reported. AEs/SAEs summarized below include all events reported and do not distinguish between being device- or procedure-related.

Other adverse events

Other adverse events
Measure	All Patients Treated With Microwave Ablation n=13 participants at risk Includes all patients treated with microwave ablation (including run-in patients)
Respiratory, thoracic and mediastinal disorders Pneumothorax	61.5% 8/13 • Number of events 8 • 1-year post-ablation From the time of the ablation procedure through 30 days post-ablation, all AEs and serious AEs (SAEs) were recorded. After 30 days post-ablation, only AEs judged by the PI as related to the study device and/or procedure and all SAEs were reported. AEs/SAEs summarized below include all events reported and do not distinguish between being device- or procedure-related.
Respiratory, thoracic and mediastinal disorders Pulmonary Hemorrhage	15.4% 2/13 • Number of events 3 • 1-year post-ablation From the time of the ablation procedure through 30 days post-ablation, all AEs and serious AEs (SAEs) were recorded. After 30 days post-ablation, only AEs judged by the PI as related to the study device and/or procedure and all SAEs were reported. AEs/SAEs summarized below include all events reported and do not distinguish between being device- or procedure-related.

Additional Information

Erin Meyers

Ethicon, Inc.

Phone: 937-681-0322

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor shall have the first right to publish the study data. If publication of the study data by the Sponsor has not occurred within eighteen (18) months of study completion/termination, the PI may publish the results from the PI his/her site individually. The PI should provide the Sponsor with at least thirty (30) days for review of the publication.
Publication restrictions are in place

Restriction type: OTHER