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NCT Number: NCT06349174

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

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.

Recruiting

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bronchoscopic lung volume reduction surgery using endobronchial valve

Procedure

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

Primary outcomes

  1. Percentage change in FEV1 relative to baseline

    Time frame: 12 weeks after surgery

    The patient will undergo lung function tests.

Secondary outcomes

  1. Percentage of subjects with FEV1 improvement ≥ 12% after bronchodilators

    Time frame: 12 weeks after surgery

    The patient will undergo lung function tests.

  2. Percentage change in RV relative to baseline

    Time frame: 12 weeks after surgery

    The patient will undergo lung function tests, and residual volume (RV) will be recorded.

  3. Percentage change in TLC relative to baseline

    Time frame: 12 weeks after surgery

    The patient will undergo lung function tests, and total lung capacity (TLC) will be recorded.

  4. Percentage change in DLCO relative to baseline

    Time frame: 12 weeks after surgery

    The patient will undergo lung function tests, and the diffusing capacity for carbon monoxide (DLCO) will be recorded.

  5. Percentage change in SGRQ score relative to baseline

    Time frame: 12 weeks after surgery

    The patient will receive a St.Georges respiratory questionnaire (SGRQ) questionnaire survey.

  6. Percentage change in mMRC grade relative to baseline

    Time frame: 12 weeks after surgery

    The patient will receive a modified Medical Research Council (mMRC) questionnaire.

  7. Percentage change in 6MWD relative to baseline

    Time frame: 12 weeks after surgery

    The patient will undergo 6-minute walk test, and 6-minute walk distance (6MWD) will be recored.

  8. the incidence of surgical-related adverse events

    Time frame: 12 weeks after surgery

    The surgical-related adverse events refers to pneumothorax, valve displacement or shedding, granuloma formation and other surgical-related adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

Gang Hou, MD

CONTACT

[email protected]

010-84205729

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 5, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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