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RecruitingNCT06969014Updated Jul 18, 2025

Transbronchial MWA for Pulmonary Tumors

An interventional study of Microwave ablation in Lung Cancer, sponsored by Shanghai Chest Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-18.

Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to evaluate the efficacy and safety of transbronchial microwave ablation for lung cancer.

02

Conditions studied

  • Lung Cancer

Browse trials for

03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 15 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥18 years old;
  2. Pathologically diagnosed as primary peripheral lung cancer, preoperative staging suggested clinical staging as T1N0M0, stage IA (including new-onset lung cancer after surgery and multiple primary lung cancer). Or it is a metastatic lung tumor, the primary lesion has been completely resected, and the maximum diameter of the tumor is ≤3cm, the number of tumors requiring intervention is ≤3.
  3. The lesion to be ablated has been evaluated as feasible for microwave ablation treatment under bronchoscopy guidance.
  4. Agree to undergo transbronchial MWA as initial treatment after being assessed unsuitable for surgery and radiotherapy or refusing surgery and radiotherapy, and sign informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Diffuse lesions in both lungs, for which ablation therapy is ineffective;
  2. Preoperative evaluation within one month reveals the presence of intrathoracic lymph node metastasis or extrapulmonary metastasis (excluding cases where extrapulmonary metastasis has been locally controlled);
  3. Contraindications to bronchoscopy, or inability to tolerate or comply with bronchoscopic procedures;
  4. Severe hemorrhagic tendency, or uncorrectable coagulation disorders (PT > 18 seconds, PTA \< 40%);
  5. Platelet count \< 70 × 10\^9/L, or ongoing anticoagulant and/or antiplatelet therapy that has not been discontinued for more than one week prior to ablation (with the exception of prophylactic low-molecular-weight heparin use);
  6. Severe pulmonary function impairment, with a maximal ventilatory volume \< 40%;
  7. Concurrent malignancies with widespread metastasis, with an expected survival of less than three months;
  8. Poor overall condition (including widespread metastasis, severe infection, high fever), infectious or radiation-induced inflammation surrounding the lesion, significant cachexia, severe organ dysfunction, severe anemia, or nutritional and metabolic disturbances that cannot be corrected in the short term;
  9. Eastern Cooperative Oncology Group (ECOG) performance status score > 2 ;
  10. Lesions planned for ablation have received radiotherapy within the past six months;
  11. Active hepatitis B, active hepatitis C, known human immunodeficiency virus (HIV) infection (HIV-1/2 antibody positive), or other active infections that may impact the patient's ability to undergo treatment as determined by the investigator;
  12. History of epilepsy, psychiatric disorders, or cognitive impairments;
  13. Patients with implanted cardiac pacemakers;
  14. Patients wearing metal jewelry or clothing with metallic components;
  15. Pregnant or lactating women, and individuals planning to conceive or become pregnant during the study period;
  16. Participation in any other clinical trial within three months prior to signing the informed consent form (non-interventional studies excluded);
  17. Any other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Transbronchial microwave ablation

    Device: Microwave ablation

Interventions

  • DeviceMicrowave ablation

    Microwave ablation of lung tumors

06

What researchers measure

Primary outcomes

  1. Complete ablation rate of main lesion at 6 months post-procedure

    6 months after ablation surgery, the proportion of patients with the main lesion maintained complete ablation among all evaluable patients who received transbronchial microwave ablation treatment.

    Time frame: 6 months

Secondary outcomes

  1. Complete ablation rate at 6 months, 12 months post-procedure (calculated in units of ablation lesions)

    This refers to the proportion of completely ablated lesions in the total ablated lesions at 6 months and 12 months after transbronchial MWA.

    Time frame: 12 months

  2. Complete ablation rate at 6 months, and 12 months post-procedure (calculated in units of patients)

    This refers to the proportion of patients with all treated lesions completely ablated in all patients who received transbronchial MWA at 6 months and 12 months after transbronchial MWA.

    Time frame: 12 months

  3. Progression-free survival rate at 12 months post-procedure

    The proportion of patients who are progression-free (without disease progression or death from any cause) at 12 months post-procedure in the total evaluable patients who received transbronchial MWA.

    Time frame: 12 months

  4. Overall survival rate at 12 months post-procedure

    The proportion of subjects who remain alive from the start of treatment until 1 year post-treatment.

    Time frame: 12 months

  5. Local progression-free survival rate at 6,12 months post-procedure

    The proportion of subjects who remain local progression-free from the start of treatment until 6,12 months post-treatment.

    Time frame: 12 months

  6. Technical success rate

    It is defined as the proportion of ablation treatment surgeries where the ablation instrument is successfully placed in the target lesion and the ablation instrument is successfully removed after the completion of the treatment procedure among all ablation treatment surgeries.

    Time frame: immediately after transbronchial MWA

  7. Safety evaluation of medical device use

    Evaluate whether the microwave therapy device's microwave output is normal and whether the cooling circulation system is normal. Evaluate whether the water flow of the disposable microwave ablation electrode is smooth, whether the rod temperature is normal, whether there is tissue adhesion during ablation, and whether there is coolant leakage.

    Time frame: immediately after transbronchial MWA

  8. ECOG Score

    The Eastern Cooperative Oncology Group (ECOG) scoring criteria were used to evaluate the physical performance status of subjects during the screening period, 7 days after treatment or before discharge, 1 month after treatment, 3 months after treatment, 6 months after treatment, and 12 months after treatment. A decrease in the score ≥1 before and after was defined as an improvement in performance status, an increase of ≥1 point was defined as a decrease in performance status, and no change in the score was stable.

    Time frame: 12 months

Other outcomes

  1. Safety of intervention

    All adverse events were recorded and evaluated according to CTCAE v5.0 (if applicable), and the relevance to the device itself and the procedure was evaluated. The incidence of device-related and procedure-related adverse events and serious adverse events was calculated.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Shanghai Chest Hospital
    Shanghai, Shanghai Municipality 200030, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06969014
Lead sponsor
Shanghai Chest Hospital
Collaborators
Canyon Medical
Responsible party
Jiayuan Sun (vice dean of the hospital, Shanghai Chest Hospital) — Principal investigator
First posted
May 13, 2025
Start date
May 12, 2025
Primary completion
Apr 22, 2026 (estimated)
Completion
Apr 22, 2027 (estimated)
Last update
Jul 18, 2025

Study contacts

Jiayuan Sun
Contact
jysun1976@163.com
+86-021-22200000 ext. 1511

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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