NCT06349174Recruiting
Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study
Source: ClinicalTrials.gov · Last updated 10 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 31 Mar 2024
- Start date
- Apr 2024
- Primary completion date
- Mar 2025
- Lead sponsor
- China-Japan Friendship Hospital
- Diseases
- COPD
- NCT number
- NCT06349174
What you commit to
- Study type: Interventional
- Planned participants: 10
- From Apr 2024 to the primary completion date, Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 4\. Hospitalization due to pulmonary infection or acute exacerbation of COPD within the past 12 months prior to baseline assessment twice or more times;
- 7\. Previous lobectomy, LVRS or lung transplantation;
- 8\. Anticoagulant therapy that cannot be stopped before surgery;
Other illness
- 3\. Obvious bronchiectasis or other infectious lung diseases;
- 6\. Myocardial infarction or congestive heart failure within the past 24 weeks;
- 9\. Uncontrolled pulmonary arterial hypertension (systolic pulmonary arterial pressure\>45mmHg) or lungs diagnosed within the past 12 weeks Arterial hypertension;
Lab values
- 5\. Coagulation dysfunction, platelet count\<60e+09/L;
- 10\. Left ventricular ejection fraction (LVEF) within the past 12 weeks is less than 45%;
Other
- 1\. Being pregnant or breastfeeding;
- 2\. PaCO2\>50mmHg and/or PaO2\<45mmHg;
- 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.
Who the study is looking for
- 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.
Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.