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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
China-Japan Friendship Hospital
RECRUITING
Beijing
Contact Information
Primary
Gang Hou, MD
hougangcmu@163.com
010-84205729
Time Frame
Start Date: 2024-04-11
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 10
Treatments
Experimental: Endobronchial valve group
The patients would undergo bronchoscopic lung volume reduction surgery using the self developed endobronchial valve.
Sponsors
Leads: China-Japan Friendship Hospital

This content was sourced from clinicaltrials.gov