NCT06349174

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Emphysema
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
PROCEDURE	bronchoscopic lung volume reduction surgery using endobronchial valve	The patients would undergo bronchoscopic lung volume reduction surgery using the self developed endobronchial valve.

Timeline

• Start date: 2024-04-11
• Primary completion: 2025-03-20
• Completion: 2025-03-31
• First posted: 2024-04-05
• Last updated: 2025-02-10

Locations

1 site across 1 country: China