[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100403734":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":146,"collaborators":42,"id":150,"slug":151,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":152,"sex":158,"minAge":159,"maxAge":160,"enrollmentInfo":161,"targetDuration":42,"studyType":164,"phases":165,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":51,"whyStopped":42,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},{"fullName":5,"class":6},"University of Zurich","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LVRS treatment group","EXPERIMENTAL","A bilateral lung volume reduction surgery (LVRS) by video-assisted thoracoscopic surgery (VATS) is performed under general anesthesia with double lumen endobronchial intubation. Unilateral treatment is accepted in cases with severe adhesions or intraoperative instability making a bilateral procedure unsafe.",[13],"Procedure: Lung volume reduction surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"BLVR study group","ACTIVE_COMPARATOR","Unilateral bronchoscopic lung volume reduction with endobronchial valves (EBV) is performed using a flexible bronchoscope under general anesthesia and under full attendance of an anesthesiologist. Valves are placed unilaterally in segmental or subsegmental bronchi in the target lobe with the goal of complete atelectasis.",[19],"Procedure: Bronchoscopic lung volume reduction with valves",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Lung volume reduction surgery","Lung volume reduction by surgery",[9],[27],"LVRS",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Bronchoscopic lung volume reduction with valves","Lung volume reduction with endobronchial valves.",[15],[33],"BLVR",[35],{"name":36,"affiliation":5,"role":37},"Isabelle Opitz, Prof. MD","PRINCIPAL_INVESTIGATOR",[39,44],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","+41 44 255 11 11",null,"isabelle.schmitt-opitz@usz.ch",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Albana Rexhepaj, PhD","+41 44 255 92 30","Albana.RexhepajBaumann@usz.ch",[49,69,84,103,119,133],{"facility":50,"status":51,"city":52,"state":42,"zip":42,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Universitätsklinik für Thoraxchirurgie, Medical University of Vienna","RECRUITING","Vienna","Austria","AT",{"type":56,"coordinates":57},"Point",[58,59],16.37208,48.20849,{"lat":59,"lon":58},[62,66],{"name":63,"role":40,"phone":64,"phoneExt":42,"email":65},"Clemens Aigner, Prof. Dr.","+43 (0)1 40400-56440","clemens.aigner@meduniwien.ac.at",{"name":67,"role":40,"phone":42,"phoneExt":42,"email":68},"Karl Kreissl","karl.kreissl@meduniwien.ac.at",{"facility":70,"status":51,"city":71,"state":42,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"University Hospital Leuven","Leuven","3000","Belgium","BE",{"type":56,"coordinates":76},[77,78],4.70093,50.87959,{"lat":78,"lon":77},[81],{"name":82,"role":40,"phone":42,"phoneExt":42,"email":83},"Laurens Ceulemans, Prof MD","laurens.ceulemans@uzleuven.be",{"facility":85,"status":51,"city":86,"state":42,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Rigshospitalet, University of Copenhagen","Copenhagen","2100","Denmark","DK",{"type":56,"coordinates":91},[92,93],12.56553,55.67594,{"lat":93,"lon":92},[96,100],{"name":97,"role":40,"phone":98,"phoneExt":42,"email":99},"Rene Horsleben Petersen, Prof. PhD","+45 35450525","rene.horsleben.petersen@regionh.dk",{"name":101,"role":40,"phone":42,"phoneExt":42,"email":102},"Tina Refstrup Lund","tina.refstrup.lund.01@regionh.dk",{"facility":104,"status":51,"city":105,"state":106,"zip":107,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Kantonsspital Aarau","Aarau","Canton of Aargau","5001","Switzerland","CH",{"type":56,"coordinates":111},[112,113],8.04422,47.39254,{"lat":113,"lon":112},[116],{"name":117,"role":40,"phone":42,"phoneExt":42,"email":118},"Franco Gambazzi, PD MD","franco.gambazzi@ksa.ch",{"facility":120,"status":51,"city":121,"state":122,"zip":123,"country":108,"countryCode":109,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Lausanne University Hospital (CHUV)","Lausanne","Canton of Vaud","1011",{"type":56,"coordinates":125},[126,127],6.63282,46.516,{"lat":127,"lon":126},[130],{"name":131,"role":40,"phone":42,"phoneExt":42,"email":132},"Thorsten Krueger, Prof MD","thorsten.krueger@chuv.ch",{"facility":134,"status":51,"city":135,"state":136,"zip":137,"country":108,"countryCode":109,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"University Hospital Zurich, Division of Thoracic Surgery","Zurich","Canton of Zurich","8091",{"type":56,"coordinates":139},[140,141],8.55,47.36667,{"lat":141,"lon":140},[144],{"name":145,"role":40,"phone":41,"phoneExt":42,"email":43},"Isabelle Opitz, Prof MD",{"type":147,"investigatorFullName":148,"investigatorTitle":149,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"SPONSOR_INVESTIGATOR","Isabelle Opitz, Professor, MD","Prof. MD","100403734","surgical-compared-to-bronchoscopic-lung-volume-reduction-in-patients-with-severe-emphysema-100403734",false,"NCT04537182","Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema","Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema: an International Multi-center Randomized Controlled Trial","SINCERE","Inclusion Criteria:\n\n* Patients suffering from emphysema (all morphologies, uni- or bilateral distribution) potentially qualifying for both study procedures, LVRS or BLVR (if possible, perfusion scintigraphy within \\\u003C 6 month of screening, CT scan within \\\u003C 4 months of screening)\n* Age ≥ 30 and ≤ 80 years\n* Body Mass Index (BMI) ≥ 16, but ≤ 35 kg\u002Fm2\n* Non-smoking for 3 months prior to screening interview\n* Patient is able to understand and willing to sign a written informed consent document.\n\nExclusion Criteria:\n\n* FEV1 more than 50% predicted\n* TLC less than 100 % predicted, RV less than 175% predicted, RV\u002FTLC less than 58% predicted, and DLCO ≤ 20% predicted in homogeneous emphysema and DLCO ≤ 15% in heterogeneous emphysema, respectively\n* PaO2 ≤ 6.0 kPa (45mm Hg) at ambient air (only applicable for homogeneous morphology!)\n* PaCO2 ≥ 6.6 kPa (50 mmHg) at ambient air (only applicable for homogeneous morphology!)\n* Patients with incomplete interlobar fissures as revealed by quantitative computed tomography analysis with StratX® (fissure completeness ≤ 80%)\n* Patients with collateral ventilation as evidenced by bronchoscopic Chartis® measurement (only performed if fissure completeness according to StratX® is \\\u003C 95%)\n* 6-minute walking distance ≥ 470m\n* More than two COPD exacerbation episodes requiring hospitalization in the last year\n* More than two instances of pneumonia episodes in the last year\n* Unplanned weight loss ≥ 10% within 90 days prior to enrollment\n* Pulmonary hypertension as evidenced by Delta Psyst RV-RA \\> 35 mmHg on recent echocardiography (within 3 months prior to screening) and confirmed by RHC (mPAP ≥ 35 mmHg) and signs of moderate to severe RV dysfunction.\n* Evidence of left ventricular ejection fraction (LVEF) less than 45% on recent echocardiography (within 3 months prior to screening)\n* History of exercise-related syncope\n* Myocardial infarction or congestive heart failure within 6 months of screening\n* Clinically significant arrhythmias that might put the patient at risk in regard to the interventions\n* Prior LVR (any method), bullectomy, or lobectomy\n* Clinically significant bronchiectasis with expectoration of ≥ 2 tablespoons\u002Fday.\n* Pulmonary nodule requiring surgery\n* Unable to safely discontinue anticoagulants or dual antiplatelet therapy for 7 days\n* Patients with a life expectancy of less than one year","ALL","30 Years","80 Years",{"count":162,"type":163},120,"ESTIMATED","INTERVENTIONAL",[166],"NA","The investigators plan to perform a randomized controlled trial that compares bilateral lung volume reduction surgery (LVRS) with bronchoscopic lung volume reduction (BLVR) using endobronchial valves in terms of efficacy and patient safety.",[169],"Emphysema",[27,33,171,172,173],"endobronchial valves","heterogeneous empyhsema","non-heterogeneous emphysema","2024-05-07",{"date":176,"type":177},"2024-05-08","ACTUAL",{"date":179,"type":177},"2020-09-01",{"date":181,"type":163},"2028-03",{"name":148,"class":6},6]