Recruiting

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

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What is being tested

bronchoscopic lung volume reduction surgery using endobronchial valve

Procedure
Who is being recruted

Chronic Disease+6

+ Emphysema

+ Lung Diseases

From 40 to 85 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2024
See protocol details

Summary

Principal SponsorChina-Japan Friendship Hospital
Study ContactGang Hou, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 11, 2024

Actual date on which the first participant was enrolled.

This study focuses on evaluating a new surgical method for people with chronic obstructive pulmonary disease (COPD) who have a type of condition called emphysema. It aims to see if using specially designed endobronchial valves during a procedure called lung volume reduction surgery can help improve lung function, increase exercise capacity, and reduce symptoms in these patients. Understanding the effectiveness and safety of these valves could offer a new way to manage emphysema, potentially providing relief for those who struggle with breathing difficulties related to this condition. Participants in this study will undergo a procedure where these endobronchial valves are placed into their lungs through a tube inserted via the mouth or nose. The study will monitor participants before the surgery and then at intervals of 3 days, 4 weeks, and 12 weeks afterward to see how their lung function and exercise capacities have changed, as well as to record any side effects from the surgery. This will help determine whether this new approach can be safely and effectively used as a treatment option for those living with emphysema.

Official TitleSafety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study
NCT06349174
Principal SponsorChina-Japan Friendship Hospital
Study ContactGang Hou, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseEmphysemaLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsDisease AttributesPulmonary Disease, Chronic Obstructive

Criteria

9 inclusion criteria required to participate
5. TLC>100% pred, RV>140% pred, and DLCO/red% ≥ 20%;

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;

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14 exclusion criteria prevent from participating
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;

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

China-Japan Friendship Hospital

Beijing, ChinaOpen China-Japan Friendship Hospital in Google Maps
Recruiting
One Study Center