Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study
NCT ID: NCT06349174
Last Updated: 2025-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2024-04-11
2025-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endobronchial valve group
The patients would undergo bronchoscopic lung volume reduction surgery using the self developed 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.
Interventions
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bronchoscopic lung volume reduction surgery using endobronchial valve
The patients would undergo bronchoscopic lung volume reduction surgery using the self developed endobronchial valve.
Eligibility Criteria
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Inclusion 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
* 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.
40 Years
85 Years
ALL
No
Sponsors
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China-Japan Friendship Hospital
OTHER
Responsible Party
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Gang Hou
Principal Investigator
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-valve-1
Identifier Type: -
Identifier Source: org_study_id
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