Lung CancerNCT06969014
Transbronchial MWA for Pulmonary Tumors
A study testing Microwave ablation in people with Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of transbronchial microwave ablation for lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- 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
- 15 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2025to 22 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years old;
- 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.
- The lesion to be ablated has been evaluated as feasible for microwave ablation treatment under bronchoscopy guidance.
- 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.
Who cannot join
- Diffuse lesions in both lungs, for which ablation therapy is ineffective;
- 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);
- Contraindications to bronchoscopy, or inability to tolerate or comply with bronchoscopic procedures;
- Severe hemorrhagic tendency, or uncorrectable coagulation disorders (PT > 18 seconds, PTA < 40%);
- 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);
- Severe pulmonary function impairment, with a maximal ventilatory volume < 40%;
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- Concurrent malignancies with widespread metastasis, with an expected survival of less than three months;
- 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;
- Eastern Cooperative Oncology Group (ECOG) performance status score > 2 ;
- Lesions planned for ablation have received radiotherapy within the past six months;
- 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;
- History of epilepsy, psychiatric disorders, or cognitive impairments;
- Patients with implanted cardiac pacemakers;
- Patients wearing metal jewelry or clothing with metallic components;
- Pregnant or lactating women, and individuals planning to conceive or become pregnant during the study period;
- Participation in any other clinical trial within three months prior to signing the informed consent form (non-interventional studies excluded);
- Any other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Jiayuan Sun, +86-021-22200000 ext. 1511, jysun1976@163.com
About this study
Official title: Treatment of Pulmonary Tumors Using Disposable Microwave Ablation Electrodes and a Microwave Ablation System Guided by Bronchoscopy: An Exploratory Study
The purpose of the study is to evaluate the efficacy and safety of transbronchial microwave ablation for lung cancer.
- Conditions
- Lung Cancer
- 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
Microwave ablation of lung tumors
| Study group | Role | What they receive |
|---|---|---|
| Transbronchial microwave ablation | Experimental | Not described Receives: Device: Microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (8)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: immediately after transbronchial MWA
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.
Measured: immediately after transbronchial MWA
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start12 May 2025
- Primary completion22 Apr 2026 (estimated)
- Study completion22 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Transbronchial MWA
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canyon Medical
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969014
- Sponsor's protocol ID
- LS25007
- Status last verified
- Jul 2025
- First submitted
- 23 Apr 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pulmonary Tumors Using Disposable Microwave Ablation Electrodes and a Microwave Ablation System Guided by Bronchoscopy: An Exploratory Study
- ClinicalTrials.gov ID
- NCT06969014
- Acronym / sponsor ID
- LS25007
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Canyon Medical
- Study start
- 12 May 2025 (actual)
- Primary completion
- 22 Apr 2026 (estimated)
- Study completion
- 22 Apr 2027 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy and safety of transbronchial microwave ablation for lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Transbronchial MWA
| Arm | Type | Receives |
|---|---|---|
| Transbronchial microwave ablation | Experimental | Device: Microwave ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old;
- 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.
- The lesion to be ablated has been evaluated as feasible for microwave ablation treatment under bronchoscopy guidance.
- 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.
Key exclusion criteria (17 listed)
- Diffuse lesions in both lungs, for which ablation therapy is ineffective;
- 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);
- Contraindications to bronchoscopy, or inability to tolerate or comply with bronchoscopic procedures;
- Severe hemorrhagic tendency, or uncorrectable coagulation disorders (PT > 18 seconds, PTA < 40%);
- 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);
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 |
|---|---|---|
| Microwave ablationMicrowave ablation of lung tumors | Device | Transbronchial microwave ablation |
Primary outcome
Complete ablation rate of main lesion at 6 months post-procedure
Time frame: 6 months
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.
8 secondary outcomes
Complete ablation rate at 6 months, 12 months post-procedure (calculated in units of ablation lesions)
Time frame: 12 months
Complete ablation rate at 6 months, and 12 months post-procedure (calculated in units of patients)
Time frame: 12 months
Progression-free survival rate at 12 months post-procedure
Time frame: 12 months
Overall survival rate at 12 months post-procedure
Time frame: 12 months
Local progression-free survival rate at 6,12 months post-procedure
Time frame: 12 months
Technical success rate
Time frame: immediately after transbronchial MWA
Safety evaluation of medical device use
Time frame: immediately after transbronchial MWA
ECOG Score
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave ablation in people with Lung Cancer, run by Shanghai Chest Hospital at 1 site 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 4 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayuan Sun (+86-021-22200000 ext. 1511, jysun1976@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete ablation rate of main lesion at 6 months post-procedure (time frame: 6 months). 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 18 Jul 2025; AzTrials last refreshed its copy on 31 Oct 2026.