Actively Recruiting
Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study
Led by China-Japan Friendship Hospital · Updated on 2025-02-10
10
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with chronic obstructive pulmonary disease based on GOLD diagnostic criteria
- Age between 40 and 85 years old, including 40 and 85
- Body mass index (BMI) of 35 kg/m2 or less
- Forced expiratory volume in 1 second (FEV1) percent predicted between 15% and 45%
- Total lung capacity (TLC) greater than 100% predicted, residual volume (RV) greater than 140% predicted, and diffusing capacity (DLCO) adjusted percent 20% or higher
- 6-minute walk distance between 100 meters and 500 meters after rehabilitation training
- Quit smoking for more than 4 months
- Negative evaluation result for pulmonary bypass ventilation function
- Signed informed consent form by participant or legal representative
You will not qualify if you...
- Pregnant or breastfeeding
- Partial pressure of carbon dioxide (PaCO2) greater than 50 mmHg and/or partial pressure of oxygen (PaO2) less than 45 mmHg
- Obvious bronchiectasis or other infectious lung diseases
- Hospitalized twice or more for pulmonary infection or acute COPD exacerbation within 12 months before baseline assessment
- Coagulation dysfunction or platelet count less than 60 x 10^9/L
- Myocardial infarction or congestive heart failure within past 24 weeks
- Previous lobectomy, lung volume reduction surgery, or lung transplantation
- Anticoagulant therapy that cannot be stopped before surgery
- Uncontrolled pulmonary arterial hypertension with systolic pressure over 45 mmHg or arterial hypertension diagnosed within past 12 weeks
- Left ventricular ejection fraction less than 45% within past 12 weeks
- Pulmonary nodules requiring intervention
- Participation in other clinical trials
- Other contraindications to bronchial operations
- Any circumstances deemed unsuitable by the researcher for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
Research Team
G
Gang Hou, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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