RecruitingNot ApplicableNCT06349174

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


Sponsor

China-Japan Friendship Hospital

Enrollment

10 participants

Start Date

Apr 11, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety and effectiveness of a bronchoscopic procedure — where small valves are placed in the airways using a flexible camera — to reduce the size of over-inflated, damaged lung areas in people with severe COPD (chronic obstructive pulmonary disease). **You may be eligible if...** - You have been diagnosed with COPD - You are between 40 and 85 years old - Your lung function tests show severe airflow limitation (FEV1 between 15–45% of expected) - You have stopped smoking for at least 4 months - You can walk between 100–500 meters in a 6-minute walking test after rehabilitation **You may NOT be eligible if...** - You are pregnant or breastfeeding - Your carbon dioxide levels are too high or oxygen levels too low on blood gas testing - You have significant bronchiectasis or active lung infection - You have been hospitalized for a lung problem in the past 3 months - You have certain heart conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREbronchoscopic lung volume reduction surgery using endobronchial valve

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


Locations(1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

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NCT06349174


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