Last updated: February 7, 2025
Sponsor: China-Japan Friendship Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Emphysema
Treatment
bronchoscopic lung volume reduction surgery using endobronchial valve
Clinical Study ID
NCT06349174
2024-valve-1
Ages 40-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with chronic obstructive pulmonary disease based on GOLD diagnosticcriteria;
- Age range from 40 to 85 years old (including 40 and 85 years old);
- BMI ≤ 35kg/m2;
- 15% ≤ FEV1% pred ≤ 45%;
- TLC>100% pred, RV>140% pred, and DLCO/red% ≥ 20%;
- 100m ≤ 6WMD ≤ 500m after rehabilitation training;
- Quit smoking for more than 4 months;
- The evaluation result of pulmonary bypass ventilation function is negative;
- Participants in this clinical trial requires the signing of an informed consentform by the individual or legal representative.
Exclusion
Exclusion Criteria:
- Being pregnant or breastfeeding;
- PaCO2>50mmHg and/or PaO2<45mmHg;
- Obvious bronchiectasis or other infectious lung diseases;
- Hospitalization due to pulmonary infection or acute exacerbation of COPD withinthe past 12 months prior to baseline assessment twice or more times;
- Coagulation dysfunction, platelet count<60e+09/L;
- Myocardial infarction or congestive heart failure within the past 24 weeks;
- Previous lobectomy, LVRS or lung transplantation;
- Anticoagulant therapy that cannot be stopped before surgery;
- Uncontrolled pulmonary arterial hypertension (systolic pulmonary arterialpressure>45mmHg) or lungs diagnosed within the past 12 weeks Arterialhypertension;
- Left ventricular ejection fraction (LVEF) within the past 12 weeks is less than 45%;
- Pulmonary nodules that require intervention;
- Patients participating in other clinical trials;
- Individuals with other contraindications to bronchial operations;
- Other circumstances that the researcher deems unsuitable for participation inthis clinical trial.
Study Design
Total Participants: 10
Treatment Group(s): 1
Primary Treatment: bronchoscopic lung volume reduction surgery using endobronchial valve
Phase:
Study Start date:
April 11, 2024
Estimated Completion Date:
March 31, 2025
Connect with a study center
China-Japan Friendship Hospital
BeiJing, Beijing 100029
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.