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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06349174
Other study ID # 2024-valve-1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 11, 2024
Est. completion date March 31, 2025

Study information

Verified date March 2024
Source China-Japan Friendship Hospital
Contact Gang Hou, MD
Phone 010-84205729
Email hougangcmu@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date March 31, 2025
Est. primary completion date March 20, 2025
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
bronchoscopic lung volume reduction surgery using endobronchial valve
The patients would undergo bronchoscopic lung volume reduction surgery using the self developed endobronchial valve.

Locations

Country Name City State
China China-Japan Friendship Hospital BeiJing Beijing

Sponsors (1)

Lead Sponsor Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage change in FEV1 relative to baseline The patient will undergo lung function tests. 12 weeks after surgery
Secondary Percentage of subjects with FEV1 improvement = 12% after bronchodilators The patient will undergo lung function tests. 12 weeks after surgery
Secondary Percentage change in RV relative to baseline The patient will undergo lung function tests, and residual volume (RV) will be recorded. 12 weeks after surgery
Secondary Percentage change in TLC relative to baseline The patient will undergo lung function tests, and total lung capacity (TLC) will be recorded. 12 weeks after surgery
Secondary 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. 12 weeks after surgery
Secondary Percentage change in SGRQ score relative to baseline The patient will receive a St.Georges respiratory questionnaire (SGRQ) questionnaire survey. 12 weeks after surgery
Secondary Percentage change in mMRC grade relative to baseline The patient will receive a modified Medical Research Council (mMRC) questionnaire. 12 weeks after surgery
Secondary Percentage change in 6MWD relative to baseline The patient will undergo 6-minute walk test, and 6-minute walk distance (6MWD) will be recored. 12 weeks after surgery
Secondary the incidence of surgical-related adverse events The surgical-related adverse events refers to pneumothorax, valve displacement or shedding, granuloma formation and other surgical-related adverse events. 12 weeks after surgery
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