Tests a lung procedure for severe emphysema in adults with the disease
Compares two ways of delivering InterVapor treatment in severe emphysema.
Plain-language title generated from the registry record
Registry title: A Multi-center RCT to Evaluate Subsegmental BTVA Treatment for Severe Emphysema
Key facts
- Where
- Beijing, Chengdu, Linyi, Nanchang, Shanghai, Shijiazhuang, Zhejiang, and Zhengzhou, ChinaSee the 9 sites
Where in China
- Emergency General HospitalBeijing, ChinaNot yet recruiting
- West China Hospital of Sichuan UniversityChengdu, ChinaNot yet recruiting
- Linyi People's HospitalLinyi, ChinaNot yet recruiting
- Jiangxi Provincial People's HospitalNanchang, ChinaNot yet recruiting
- Shanghai Chest HospitalShanghai, ChinaTaking people
- Shanghai Sixth People's HospitalShanghai, ChinaNot yet recruiting
- Hebei Provincial People's HospitalShijiazhuang, ChinaNot yet recruiting
- Sir Run Run Shaw Hospital affiliated to Zhejiang University School of MedicineZhejiang, ChinaTaking people
- Henan Provincial People's HospitalZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Chest Hospital
- Trial code
- NCT06152107
- Record updated
- 8 September 2025
- Original description
To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysemaRead full original descriptionShow less
A Multi-center, Randomized Controlled Study to Evaluate the Efficacy and Safety of Precise Subsegmental Treatment With InterVapor for Severe Emphysema
To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema
Inclusion: Age≥18 years old; Patients with severe emphysema and with at least two treatable subsegments and 1 treatable segment in the ipsilateral lung assessed by QCT; Non-smoking for 2 months prior to study enrollment, and remain abstinent from smoking for the duration of the study; 15%predicted≤FEV1≤50%predicted, TLC≥100% predicted, RV≥150% predicted (and RV/ TLC≥55%); 6MWD >140 meters (patients with lower limb disability or motor dysfunction will be exempted from the test); mMRC score≥2; Arterial blood gas levels of: PaCO2≤55 mmHg; PaO2>50 mmHg on room air; Mentally and physically able to cooperate with the study procedures and to provide informed consent prior to study enrollment.
Exclusion: 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; Use of morphine derivatives within 4 weeks prior to screening; 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.); Highly suspicious malignant pulmonary nodules in the lungs as assessed by specialist; Any conditions assessed by investigator that make patients inappropriate for enrolment; 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; Presence of active pathogen related infection or symptoms indicative of active infection (e.g. fever, elevated WBC, etc.); Taking more than 10 mg prednisolone or equivalent daily glucocorticoids at the screening visit; Recent COPD exacerbation in preceding 6 weeks; 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%; Presence of single large bulla (defined as > 1/3 volume of lobe) or a paraseptal distribution of emphysema in the target lobe; Pregnant or breastfeeding; Current enrollment in any other investigational study which has not completed requisite follow-up.