About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%;
Disqualifiers
1. Being pregnant or breastfeeding;
2. PaCO2>50mmHg and/or PaO2<45mmHg;
3. Obvious bronchiectasis or other infectious lung diseases;
4. Hospitalization due to pulmonary infection or acute exacerbation of COPD within the past 12 months prior to baseline assessment twice or more times;
Trial design
Single group
Treatments tested in this trial
bronchoscopic lung volume reduction surgery using endobronchial valve
Procedure/SurgeryThe patients would undergo bronchoscopic lung volume reduction surgery using the self developed endobronchial valve.
Treatment groups
Trial outcomes
Primary outcomes
Percentage change in FEV1 relative to baseline
The patient will undergo lung function tests.
Secondary outcomes
Percentage of subjects with FEV1 improvement ≥ 12% after bronchodilators
The patient will undergo lung function tests.
Percentage change in RV relative to baseline
The patient will undergo lung function tests, and residual volume (RV) will be recorded.
Percentage change in TLC relative to baseline
The patient will undergo lung function tests, and total lung capacity (TLC) will be recorded.
Percentage change in DLCO relative to baseline
The patient will undergo lung function tests, and the diffusing capacity for carbon monoxide (DLCO) will be recorded.
Sponsors and contacts
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