Status:
RECRUITING
A Multi-center RCT to Evaluate Subsegmental BTVA Treatment for Severe Emphysema
Lead Sponsor:
Shanghai Chest Hospital
Conditions:
Severe Emphysema
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06152107
Start Date
January 1 2024
End Date
December 31 2027
Last Update
September 8 2025
Active Locations (9)
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1
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
2
Emergency General Hospital
Beijing, China, 100028
3
West China Hospital of Sichuan University
Chengdu, China, 610041
4
Linyi People's Hospital
Linyi, China