NCT06349174 Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study
| NCT ID | NCT06349174 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China-Japan Friendship Hospital |
| Condition | Emphysema |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-04-11 |
| Primary Completion | 2025-03-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-04-11 with a primary completion date of 2025-03-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06349174 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Emphysema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06349174 currently recruiting?
Yes, NCT06349174 is actively recruiting participants. Contact the research team at hougangcmu@163.com for enrollment information.
Where is the NCT06349174 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06349174 clinical trial?
NCT06349174 is sponsored by China-Japan Friendship Hospital. The trial plans to enroll 10 participants.