Subsegmental versus segmental thermal vapor ablation for severe emphysema

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Chest Hospital (Academic / other)
• Locations: 9 sites (Zhengzhou, Henan and 8 other locations)
• Trial ID: NCT06152107 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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

Eligibility 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 this trial is running

Zhengzhou, Henan and 8 other locations

• Henan Provincial People's Hospital — Zhengzhou, Henan, 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)
• Jiangxi Provincial People's Hospital — Nanchang, China (Not_yet_recruiting)
• Shanghai Chest Hospital — Shanghai, China (Recruiting)
• Shanghai Sixth People's Hospital — Shanghai, China (Not_yet_recruiting)
• Hebei Provincial People's Hospital — Shijiazhuang, China (Not_yet_recruiting)
• Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine — Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Jiayuan Sun, MD., PhD.

Conditions Severe Emphysema; Bronchoscopic Thermal Vapor Ablation; Chronic obstructive pulmonary disease; Severe emphysema; Bronchoscopic lung volume reduction