A Multi-center RCT to Evaluate Subsegmental BTVA Treatment for Severe Emphysema
Recruiting now · Not applicable
Conditions studied: Severe Emphysema
In brief
To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema
Key facts
- Study ID
- NCT06152107
- Run by
- Shanghai Chest Hospital
- People needed
- 100
- Starts
- 2024-01-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-09-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
- 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;
- 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;
- Presence of active pathogen related infection or symptoms indicative of active infection (e.g. fever, elevated WBC, etc.);
- 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;
- Pregnant or breastfeeding;
- Current enrollment in any other investigational study which has not completed requisite follow-up;
- Any conditions assessed by investigator that make patients inappropriate for enrolment.
Where it is running
- Henan Provincial People's Hospital — Zhengzhou, Henan, China (enrolling)
- Shanghai Chest Hospital — Shanghai, China (enrolling)
- Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine — Zhejiang, China (enrolling)
- Linyi People's Hospital — Linyi, China
- Jiangxi Provincial People's Hospital — Nanchang, China
- Hebei Provincial People's Hospital — Shijiazhuang, China
- Shanghai Sixth People's Hospital — Shanghai, China
- Emergency General Hospital — Beijing, China
- West China Hospital of Sichuan University — Chengdu, China
Full record on ClinicalTrials.gov
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