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Clinical trial Recruiting at 3 sites Interventional Ages 18 and up

Subsegmental versus segmental thermal vapor ablation for severe emphysema

Official title: A Multi-center, Randomized Controlled Study to Evaluate the Efficacy and Safety of Precise Subsegmental Treatment With InterVapor for Severe Emphysema

Run by Shanghai Chest Hospital · NCT06152107 · Data updated 2026-11-12

This trial tests whether treating smaller lung subsegments with bronchoscopic thermal vapor ablation works better and is as safe as treating whole segments for people with severe emphysema.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorShanghai Chest Hospital
Academic / other
Locations9 sites (Zhengzhou, Henan and 8 other locations)
StatusRecruiting
StartedJanuary 1, 2024
Main results expectedDecember 31, 2026
Study endsDecember 31, 2027
Registry record updatedSeptember 8, 2025
Trial IDNCT06152107 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with severe emphysema who are non-smokers for at least 2 months, have FEV1 15–50% predicted, RV ≥150% predicted, mMRC ≥2, acceptable blood gases (PaCO2 ≤55 mmHg, PaO2 >50 mmHg on room air), a 6MWD >140 m, and at least two treatable subsegments plus one treatable segment on QCT.

Probably not a fit

Patients with contraindications to bronchoscopy or significant cardiac disease, active smokers, those with inadequate target anatomy on QCT, or very severe hypercapnia are unlikely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, multi-center trial in China compares subsegmental versus segmental bronchoscopic thermal vapor ablation (BTVA) using the InterVapor system, each combined with guideline-based medical therapy. Eligible adults with severe emphysema are selected by quantitative CT to have at least two treatable subsegments and one treatable segment in the same lung, and are randomized to receive either focused subsegmental or larger segmental vapor ablation. Outcomes include safety and measures of lung function, exercise capacity, symptoms, and exacerbations over follow-up, with procedures performed via bronchoscopy under standard peri-procedural care. Non-smokers who meet spirometric and blood-gas criteria and can tolerate bronchoscopy are enrolled at three tertiary hospitals.

Why it matters

Potential benefit: If successful, the subsegmental approach could improve breathing and exercise ability while reducing treatment-related damage by targeting smaller areas of diseased lung.

How similar studies have gone: Bronchoscopic thermal vapor ablation has shown benefit in prior studies for heterogeneous emphysema, but randomized comparisons directly contrasting subsegmental versus segmental approaches are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age≥18 years old;
2. Patients with severe emphysema and with at least two treatable subsegments and 1 treatable segment in the ipsilateral lung assessed by QCT;
3. Non-smoking for 2 months prior to study enrollment, and remain abstinent from smoking for the duration of the study;
4. 15%predicted≤FEV1≤50%predicted, TLC≥100% predicted, RV≥150% predicted (and RV/ TLC≥55%);
5. 6MWD \>140 meters (patients with lower limb disability or motor dysfunction will be exempted from the test)
6. mMRC score≥2;
7. Arterial blood gas levels of: PaCO2≤55 mmHg; PaO2\>50 mmHg on room air;
8. Mentally and physically able to cooperate with the study procedures and to provide informed consent prior to study enrollment.

Exclusion Criteria:

1. Contraindications to bronchoscopy, such as:

   Prior myocardial infarction within 1 month, unstable myocardial ischaemia, ejection fraction (EF) ≤ 40%; Active haemoptysis; Coagulation disorders; Malignant cardiac arrhythmia, severe pulmonary hypertension, extreme systemic failure, etc;
2. Concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with InterVapor. Examples of particular relevance include: immune system disorders, immunosuppressant medications of clinical relevance, bleeding disorders and unstable cardiovascular conditions, history of asthma or alpha-1 antitrypsin deficiency;
3. Use of morphine derivatives within 4 weeks prior to screening;
4. Taking more than 10 mg prednisolone or equivalent daily glucocorticoids at the screening visit;
5. Recent COPD exacerbation in preceding 6 weeks;
6. Severe emphysema in both the upper and lower lobes of the contralateral lungs, defined as %LAA-950 assessed by HRCT as a percentage of whole lung lobe volume \> 40%;
7. Presence of single large bulla (defined as \> 1/3 volume of lobe) or a paraseptal distribution of emphysema in the target lobe;
8. Presence of active pathogen related infection or symptoms indicative of active infection (e.g. fever, elevated WBC, etc.);
9. History of heart and/or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, thoracic surgery with removal of lung tissue and endobronchial lung volume reduction (via valves, coils, stents, etc.);
10. Highly suspicious malignant pulmonary nodules in the lungs as assessed by specialist;
11. Pregnant or breastfeeding;
12. Current enrollment in any other investigational study which has not completed requisite follow-up;
13. Any conditions assessed by investigator that make patients inappropriate for enrolment.

Where it's running

  • Henan Provincial People's Hospital
    Zhengzhou, Henan, China     Recruiting
  • Shanghai Chest Hospital
    Shanghai, China     Recruiting
  • Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine
    Zhejiang, China     Recruiting
  • Emergency General Hospital
    Beijing, China     Not yet recruiting
  • West China Hospital of Sichuan University
    Chengdu, China     Not yet recruiting
  • Linyi People's Hospital
    Linyi, China     Not yet recruiting
Show 3 more locations
  • Jiangxi Provincial People's Hospital
    Nanchang, China     Not yet recruiting
  • Shanghai Sixth People's Hospital
    Shanghai, China     Not yet recruiting
  • Hebei Provincial People's Hospital
    Shijiazhuang, China     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Severe Emphysema 2Shanghai Chest Hospital 48
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.