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

Last updated: February 7, 2025
Sponsor: China-Japan Friendship Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Emphysema

Treatment

bronchoscopic lung volume reduction surgery using endobronchial valve

Clinical Study ID

NCT06349174
2024-valve-1
  • Ages 40-85
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Patients with chronic obstructive pulmonary disease based on GOLD diagnosticcriteria;
  1. Age range from 40 to 85 years old (including 40 and 85 years old);
  1. BMI ≤ 35kg/m2;
  1. 15% ≤ FEV1% pred ≤ 45%;
  1. TLC>100% pred, RV>140% pred, and DLCO/red% ≥ 20%;
  1. 100m ≤ 6WMD ≤ 500m after rehabilitation training;
  1. Quit smoking for more than 4 months;
  1. The evaluation result of pulmonary bypass ventilation function is negative;
  1. Participants in this clinical trial requires the signing of an informed consentform by the individual or legal representative.

Exclusion

Exclusion Criteria:

  1. Being pregnant or breastfeeding;
  1. PaCO2>50mmHg and/or PaO2<45mmHg;
  1. Obvious bronchiectasis or other infectious lung diseases;
  1. Hospitalization due to pulmonary infection or acute exacerbation of COPD withinthe past 12 months prior to baseline assessment twice or more times;
  1. Coagulation dysfunction, platelet count<60e+09/L;
  1. Myocardial infarction or congestive heart failure within the past 24 weeks;
  1. Previous lobectomy, LVRS or lung transplantation;
  1. Anticoagulant therapy that cannot be stopped before surgery;
  1. Uncontrolled pulmonary arterial hypertension (systolic pulmonary arterialpressure>45mmHg) or lungs diagnosed within the past 12 weeks Arterialhypertension;
  1. Left ventricular ejection fraction (LVEF) within the past 12 weeks is less than 45%;
  1. Pulmonary nodules that require intervention;
  1. Patients participating in other clinical trials;
  1. Individuals with other contraindications to bronchial operations;
  1. Other circumstances that the researcher deems unsuitable for participation inthis clinical trial.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: bronchoscopic lung volume reduction surgery using endobronchial valve
Phase:
Study Start date:
April 11, 2024
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • China-Japan Friendship Hospital

    BeiJing, Beijing 100029
    China

    Active - Recruiting

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