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Cancer of the LungNCT04889989

Microwave Ablation in Chinese Patients With Lung Tumors

A study testing Microwave Ablation in people with Cancer of the Lung, run by Ethicon, Inc. at 8 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Adult patients with non-small cell lung cancer (NSCLC) or oligometastatic lung tumors will all receive microwave ablation (MWA) performed percutaneously by doctors who are experienced in lung tumor ablation. 120 patients will participate across 8 clinical study sites all in China. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer of the Lung
What is being tested?
Microwave Ablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
8 sitesChina
Study dates
27 Dec 2021to 14 Sep 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed the informed consent form and willing to fulfill the study-related assessments and procedure schedule.
  • Lung tumor patients ≥ 18 years of age who are ineligible for/decline surgery and who plan to receive microwave ablation therapy.
  • ECOG performance status score of 0-2.
  • Patients with stages IA1-IA2 NSCLC with documented results from a biopsy or patients with clinically diagnosed oligometastatic lung tumor.
  • Tumor(s) to be ablated in a single surgery should be a maximum of one NSCLC tumor or a maximum of three ipsilateral oligometastatic lung tumors.
  • Tumor(s) to be ablated in a single surgery should be ≤ 2cm, locate in the outer two-thirds of a lung, not closer than 1 cm from the hilum of lung, great vessels, principal bronchus, trachea or esophagus, and not contiguous with the pleura.

Who cannot join

  • Pregnant or breast-feeding.
  • Patients with implantable pacemakers or other electronic implants.
  • Oligometastatic tumors patients whose primary lesion cannot be controlled or have widely metastases, in the opinion of the investigator and/or treating oncologist.
  • Any planned concurrent procedure at the time of ablation.
  • Planned treatment for other tumors in the same side lung during the study period.
  • With a skin infection or ulceration at the site to be punctured by probe(s).
Show all 28Show fewer
  • Clinical or imaging findings consistent with an active pulmonary infection.
  • Patients with severe pulmonary fibrosis in the area intended to ablate, especially drug-induced pulmonary fibrosis.
  • Patients with prior radiotherapy in the area intended to ablate.
  • Patients with uncontrolled malignant pleural effusion at the lung side with tumor to ablate.
  • Tumors where the anticipated zone of ablation would encompass significant (in the opinion of the treating physician) emphysematous or bullous disease.
  • The investigator anticipates that the ablation zone of the multiple tumor(s) to be ablated may have overlapping ablation zones.
  • Patients who have received lung ablation or surgical resection therapy within 30 days prior to the ablation procedure under study and those who plan to receive lung tumor ablation or surgical resection therapy or radiation therapy on the ablated lung side before completing the primary efficacy endpoint assessment approximately 30 days after the ablation procedure.
  • Patients who received systemic therapy such as chemotherapy, targeted drug therapy, or immunotherapy within 7 days prior to the ablation procedure under study, and patients who had a systemic treatment plan such as chemotherapy, targeted drug therapy, immunotherapy, etc. before completing the primary efficacy endpoint assessment approximately 30 days after the ablation procedure.
  • Patients with uncorrectable coagulopathy based on investigator judgment.
  • Patients with a platelet count ≤ 50 × 109/L.
  • Patients who cannot discontinue antiplatelet medication (e.g., aspirin, clopidogrel, prasugrel, ticagrelor) at least 5 days before the ablation procedure through 24 hours post-procedure.
  • Patients who cannot discontinue anticoagulant medication (e.g., rivaroxaban, apixaban, dabigatran, edoxaban) at least 3 days before the ablation procedure through 24 hours post-procedure.
  • Patients who cannot discontinue warfarin before at least 5 days before the ablation procedure of the study or have an INR > 1.5.
  • As judged by the investigator, the patient has hypertension that cannot be effectively controlled by pharmacological treatments.
  • Severe hepatic, renal, cardiac, pulmonary or cerebral insufficiency, severe anemia, dehydration, and severe nutrition and metabolism disorders, which cannot be corrected or improved within a short term; or serious systemic infection; or severe neuromuscular diseases.
  • Expected survival less than 6 months.
  • Participation in any other interventional clinical study within 30 days before screening.
  • Physical or psychological condition which would impair study participation.
  • Patient is judged unsuitable for study participation by the investigator for any other reason.
  • Intra-Ablation Exclusion Criteria:
  • Before ablation probe puncture on the skin, patient is judged unsuitable for study participation due to intolerance to anesthesia.
  • Before ablation probe puncture on the skin, patient is judged unsuitable for study participation due to presenting any other condition.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Beijing Hospital

    Beijing

  • Pecking University Shenzhen Hospital

    Beijing

  • The First Affiliated Hospital of Fujian Medical University

    Fujian

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin

  • Henan Cancer Hospital

    Henan

  • Hunan Cancer Hospital

    Hunan

  • Qilu Hospital of Shandong University

    Shandong

  • Fudan University Shanghai Cancer Hospital

    Shanghai

Other trials in China

About this study

Official title: A Single-Arm, Prospective, Multicenter Study to Evaluate the Effectiveness and Safety of the NeuWave Certus Microwave Ablation System in Chinese Patients With Primary or Secondary Tumors in the Lung

Adult patients with non-small cell lung cancer (NSCLC) or oligometastatic lung tumors will all receive microwave ablation (MWA) performed percutaneously by doctors who are experienced in lung tumor ablation. 120 patients will participate across 8 clinical study sites all in China.

Being tested
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.

  • Microwave AblationDevice

    Percutaneous microwave ablation using the NeuWave Microwave Ablation System for non-small cell lung cancer or oligometastatic lung tumors

Study groups in NCT04889989
Study groupRoleWhat they receive
Microwave Ablation of Lung TumorOtherAdult patients with non-small cell lung cancer (NSCLC) or oligometastatic lung tumors who plan to receive percutaneous microwave ablation.
Receives: Device: Microwave Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Technical Efficacy Rate

    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.

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

Secondary outcomes (4)

  1. Technical Success Rate

    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.

    Measured: Ablation Day (day 0)

  2. Local Tumor Progression

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

    Measured: 1 year post-ablation

  3. Overall Survival

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

    Measured: 1-year post-ablation

  4. Progression-Free Survival

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

    Measured: 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.

  1. First posted18 May 2021
  2. Study start27 Dec 2021
  3. Primary completion22 Oct 2022
  4. Study completion14 Sep 2023

Why it stopped: Change in company strategy.

Resources

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
Not applicable
Intervention model
Single group
Model description
Single-arm, prospective, multicenter clinical trial with a performance goal
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04889989
Sponsor's protocol ID
NEU_2020_02
Status last verified
Jan 2026
First submitted
12 May 2021
Last updated
4 Feb 2026
Data monitoring committee
No
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.

Questions about this trial

What is this clinical trial studying?

A study testing Microwave Ablation in people with Cancer of the Lung, run by Ethicon, Inc. at 8 sites in China.

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 28 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. 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 15 Oct 2024). 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?

Technical Efficacy Rate (time frame: 30 days (+/- 7 days) post-ablation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04889989.

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 4 Feb 2026.

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