Evaluating a new valve for lung volume reduction in COPD patients

Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study

This study is testing a new valve to see if it can safely help people with COPD and emphysema breathe better and feel more active after a lung procedure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: China-Japan Friendship Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06349174 on ClinicalTrials.gov

What this trial studies

This pilot study aims to assess the safety and effectiveness of a self-developed endobronchial valve used in bronchoscopic lung volume reduction surgery for patients with emphysema and chronic obstructive pulmonary disease (COPD). Participants will undergo the procedure and will be monitored for improvements in lung function, exercise capacity, and symptoms, as well as any surgery-related adverse events. Follow-up assessments will occur at baseline, 3 days, 4 weeks, and 12 weeks post-surgery to evaluate outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 to 85 with COPD and emphysema who meet specific lung function criteria.

Not a fit: Patients with severe respiratory failure or other significant comorbidities may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could significantly improve lung function and quality of life for patients with severe COPD.

How similar studies have performed: While similar approaches have been explored, this specific use of self-developed endobronchial valves is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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;
* 5\. Coagulation dysfunction, platelet count\<60e+09/L;
* 6\. Myocardial infarction or congestive heart failure within the past 24 weeks;
* 7\. Previous lobectomy, LVRS or lung transplantation;
* 8\. Anticoagulant therapy that cannot be stopped before surgery;
* 9\. Uncontrolled pulmonary arterial hypertension (systolic pulmonary arterial pressure\>45mmHg) or lungs diagnosed within the past 12 weeks Arterial hypertension;
* 10\. Left ventricular ejection fraction (LVEF) within the past 12 weeks is less than 45%;
* 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.

Where this trial is running

Beijing, Beijing Municipality

• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Gang Hou, MD

Conditions Emphysema; Chronic Obstructive Pulmonary Disease