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

NCT06349174 · tracked via the Priya Life Science Japan tracker

Sponsor

China-Japan Friendship Hospital

Phase

Not applicable

Started

2024-04-11

Last updated

2025-02-10

Condition(s) studied

EmphysemaChronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

bronchoscopic lung volume reduction surgery using endobronchial valve

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

Study 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

Sex

ALL

Min age

40 Years

Max age

85 Years

Healthy volunteers

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.

Primary outcome measure(s)

Percentage change in FEV1 relative to baseline — 12 weeks after surgery
The patient will undergo lung function tests.

Trial sites (1)

Facility	City	Region	Status
China-Japan Friendship Hospital	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06349174 on ClinicalTrials.gov ↗ ← All trials in Japan