Tests an endobronchial valve procedure for emphysema in people with COPD
Tests a small valve placed through the airways to shrink damaged lung areas.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 85 years old?
Source: NCT06349174, who can take part
Where in China
- China-Japan Friendship HospitalBeijing, 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
- China-Japan Friendship Hospital
- Trial code
- NCT06349174
- Record updated
- 10 February 2025
- Original description
The goal of this pliot study al is to preliminarily evaluate the effectiveness and safety of transbronchial lung volume reduction surgery using the self-devloped endobronchial valves for chronic obstructive pulmonary disease patients with emphysema phenotype . The main questions it aims to answer are:Read full original descriptionShow less
Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study
The goal of this pliot study al is to preliminarily evaluate the effectiveness and safety of transbronchial lung volume reduction surgery using the self-devloped endobronchial valves for chronic obstructive pulmonary disease patients with emphysema phenotype . The main questions it aims to answer are:
Does self-devloped endobronchial valves improve the lung function、exercise capacity and symptons of participants? What surgery-related adverse events do participants have after transbronchial lung volume reduction surgery using the self-devloped endobronchial valves?
Participants will:
undergo transbronchial lung volume reduction surgery using the self-devloped endobronchial valves.
receive follow-up before surgery (baseline) and 3 days, 4 weeks, 12weeks after surgery.
Inclusion: 1. Patients with chronic obstructive pulmonary disease based on GOLD diagnostic criteria; 2. Age range from 40 to 85 years old (including 40 and 85 years old); 3. BMI ≤ 35kg/m2; 4. 15% ≤ FEV1% pred ≤ 45%; 5. TLC>100% pred, RV>140% pred, and DLCO/red% ≥ 20%; 6. 100m ≤ 6WMD ≤ 500m after rehabilitation training; 7. Quit smoking for more than 4 months; 8. The evaluation result of pulmonary bypass ventilation function is negative; 9. Participants in this clinical trial requires the signing of an informed consent form by the individual or legal representative.
Exclusion: 4. Hospitalization due to pulmonary infection or acute exacerbation of COPD within the past 12 months prior to baseline assessment twice or more times; 7. Previous lobectomy, LVRS or lung transplantation; 8. Anticoagulant therapy that cannot be stopped before surgery; 3. Obvious bronchiectasis or other infectious lung diseases; 6. Myocardial infarction or congestive heart failure within the past 24 weeks; 9. Uncontrolled pulmonary arterial hypertension (systolic pulmonary arterial pressure>45mmHg) or lungs diagnosed within the past 12 weeks Arterial hypertension; 5. Coagulation dysfunction, platelet count<60e+09/L; 10. Left ventricular ejection fraction (LVEF) within the past 12 weeks is less than 45%; 1. Being pregnant or breastfeeding; 2. PaCO2>50mmHg and/or PaO2<45mmHg; 11. Pulmonary nodules that require intervention; 12. Patients participating in other clinical trials; 13. Individuals with other contraindications to bronchial operations; 14. Other circumstances that the researcher deems unsuitable for participation in this clinical trial.