Evaluating a new valve for lung volume reduction in COPD patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Gang Hou, MD
• Email: hougangcmu@163.com
• Phone: 010-84205729

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.