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Recruiting NCT06349174

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

No phase Interventional Emphysema Chronic Obstructive Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: bronchoscopic lung volume reduction surgery using endobronchial valve.
Who it may be relevant to
Registry conditions: Emphysema, Chronic Obstructive Pulmonary Disease. Basic parameters: 40 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

  • Percentage change in FEV1 relative to baseline [Time frame: 12 weeks after surgery]
Secondary outcome measures (8)
  • Percentage of subjects with FEV1 improvement ≥ 12% after bronchodilators [Time frame: 12 weeks after surgery]
  • Percentage change in RV relative to baseline [Time frame: 12 weeks after surgery]
  • Percentage change in TLC relative to baseline [Time frame: 12 weeks after surgery]
  • Percentage change in DLCO relative to baseline [Time frame: 12 weeks after surgery]
  • Percentage change in SGRQ score relative to baseline [Time frame: 12 weeks after surgery]
  • Percentage change in mMRC grade relative to baseline [Time frame: 12 weeks after surgery]
  • Percentage change in 6MWD relative to baseline [Time frame: 12 weeks after surgery]
  • the incidence of surgical-related adverse events [Time frame: 12 weeks after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • China-Japan Friendship Hospital — Beijing

Identifiers

NCT: NCT06349174 · 2024-valve-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗