[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542923":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":48,"collaborators":19,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":19,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":19,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":19,"overallStatus":28,"whyStopped":19,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"China-Japan Friendship Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Endobronchial valve group","EXPERIMENTAL","The patients would undergo bronchoscopic lung volume reduction surgery using the self developed endobronchial valve.",[13],"Procedure: bronchoscopic lung volume reduction surgery using endobronchial valve",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"PROCEDURE","bronchoscopic lung volume reduction surgery using endobronchial valve",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Gang Hou, MD","CONTACT","010-84205729","hougangcmu@163.com",[27],{"facility":5,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Beijing","Beijing Municipality","100029","China","CN",{"type":35,"coordinates":36},"Point",[37,38],116.39723,39.9075,{"lat":38,"lon":37},[41,44],{"name":42,"role":23,"phone":43,"phoneExt":19,"email":25},"Gang Hou, Professor","13840065481",{"name":45,"role":23,"phone":46,"phoneExt":19,"email":47},"Mingming Deng, Doctor","18801336854","isdeng1017@163.com",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Gang Hou","Principal Investigator","100542923","safety-and-efficacy-of-endobronchial-valve-for-bronchoscopic-lung-volume-reduction-surgery-a-prospective-pilot-study-100542923",false,"NCT06349174","Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study","Inclusion Criteria:\n\n* 1\\. Patients with chronic obstructive pulmonary disease based on GOLD diagnostic criteria;\n* 2\\. Age range from 40 to 85 years old (including 40 and 85 years old);\n* 3\\. BMI ≤ 35kg\u002Fm2;\n* 4\\. 15% ≤ FEV1% pred ≤ 45%;\n* 5\\. TLC\\>100% pred, RV\\>140% pred, and DLCO\u002Fred% ≥ 20%;\n* 6\\. 100m ≤ 6WMD ≤ 500m after rehabilitation training;\n* 7\\. Quit smoking for more than 4 months;\n* 8\\. The evaluation result of pulmonary bypass ventilation function is negative;\n* 9\\. Participants in this clinical trial requires the signing of an informed consent form by the individual or legal representative.\n\nExclusion Criteria:\n\n* 1\\. Being pregnant or breastfeeding;\n* 2\\. PaCO2\\>50mmHg and\u002For PaO2\\\u003C45mmHg;\n* 3\\. Obvious bronchiectasis or other infectious lung diseases;\n* 4\\. Hospitalization due to pulmonary infection or acute exacerbation of COPD within the past 12 months prior to baseline assessment twice or more times;\n* 5\\. Coagulation dysfunction, platelet count\\\u003C60e+09\u002FL;\n* 6\\. Myocardial infarction or congestive heart failure within the past 24 weeks;\n* 7\\. Previous lobectomy, LVRS or lung transplantation;\n* 8\\. Anticoagulant therapy that cannot be stopped before surgery;\n* 9\\. Uncontrolled pulmonary arterial hypertension (systolic pulmonary arterial pressure\\>45mmHg) or lungs diagnosed within the past 12 weeks Arterial hypertension;\n* 10\\. Left ventricular ejection fraction (LVEF) within the past 12 weeks is less than 45%;\n* 11\\. Pulmonary nodules that require intervention;\n* 12\\. Patients participating in other clinical trials;\n* 13\\. Individuals with other contraindications to bronchial operations;\n* 14\\. Other circumstances that the researcher deems unsuitable for participation in this clinical trial.","ALL","40 Years","85 Years",{"count":62,"type":63},10,"ESTIMATED","INTERVENTIONAL",[66],"NA","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:\n\nDoes 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?\n\nParticipants will:\n\nundergo transbronchial lung volume reduction surgery using the self-devloped endobronchial valves.\n\nreceive follow-up before surgery (baseline) and 3 days, 4 weeks, 12weeks after surgery.",[69,70],"Emphysema","Chronic Obstructive Pulmonary Disease","2025-02-07",{"date":73,"type":74},"2025-02-10","ACTUAL",{"date":76,"type":74},"2024-04-11",{"date":78,"type":63},"2025-03-31",{"name":5,"class":6},1]