[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494362":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":34,"responsibleParty":227,"collaborators":18,"id":229,"slug":230,"hasResults":231,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":18,"eligibilityCriteria":235,"healthyVolunteers":231,"sex":236,"minAge":237,"maxAge":238,"enrollmentInfo":239,"targetDuration":18,"studyType":242,"phases":243,"briefSummary":245,"conditions":246,"keywords":18,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":257},{"fullName":5,"class":6},"IHF GmbH - Institut für Herzinfarktforschung","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"InterVapor®-System","ACTIVE_COMPARATOR","The intervention to be tested is bronchoscopic lung volume reduction (BTVA) using thermal ablation (InterVapor®, Uptake Medical, California, USA). This is performed in addition to standard conservative therapy in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines. The intervention can consist of a maximum of two partial interventions",[13],"Device: InterVapor®-System",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care","NO_INTERVENTION","Standard conservative therapy in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines without the use of a BTVA (patient-specific documentation of therapeutic measures).",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DEVICE","The InterVapor System uses heated water vapor to ablate the airways and parenchyma within targeted regions of the lung. Lung remodeling occurs after an initial localized inflammatory response and a subsequent healing and repair. The remodeling of the tissue results in reductions in tissue and air volume in the targeted regions of the lung. The remodeled lung tissue does not re-inflate as a result of collateral ventilation.\n\nThe lung volume reduction of diseased hyper-inflated lung segments after InterVapor treatment is expected to increase elastic recoil by reducing the most compliant segments of the lung, decompressing segments of healthier lung allowing for alveolar recruitment, and improving the mechanical efficiency of the respiratory muscles. These mechanical changes are anticipated to improve pulmonary function, exercise capacity and quality of life.",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Felix Herth, MD","CONTACT","+49 6221 396 1200","felix.herth@med.uni-heidelberg.de",{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},"Leschek Brachmann, Masters of Science","+49 621 59577 225","leschek.brachmann@ihf.de",[35,56,71,87,102,117,130,149,164,182,197,212],{"facility":36,"status":37,"city":38,"state":18,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Charité Campus Benjamin Franklin","RECRUITING","Berlin","13353","Germany","DE",{"type":43,"coordinates":44},"Point",[45,46],13.41053,52.52437,{"lat":46,"lon":45},[49,53],{"name":50,"role":27,"phone":51,"phoneExt":18,"email":52},"Ralf-Harto Hübner, Dr. med.","0049 30-450 653787","ralf-harto.huebner@charite.de",{"name":54,"role":55,"phone":18,"phoneExt":18,"email":18},"Ralf-Harto Hübner, Dr.","PRINCIPAL_INVESTIGATOR",{"facility":57,"status":37,"city":38,"state":18,"zip":58,"country":40,"countryCode":41,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin","14089",{"type":43,"coordinates":60},[45,46],{"lat":46,"lon":45},[63,67,70],{"name":64,"role":27,"phone":65,"phoneExt":18,"email":66},"Hannah Wüstefeld, Dr. med.","0049 30 365 280","lunge@havelhoehe.de",{"name":68,"role":27,"phone":18,"phoneExt":18,"email":69},"Christian Grah, Dr. med.","christian.grah@havelhoehe.de",{"name":64,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":72,"status":73,"city":74,"state":18,"zip":75,"country":40,"countryCode":41,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II","NOT_YET_RECRUITING","Bonn","53127",{"type":43,"coordinates":77},[78,79],7.09549,50.73438,{"lat":79,"lon":78},[82,86],{"name":83,"role":27,"phone":84,"phoneExt":18,"email":85},"Dirk Skowasch, Prof.","+49 228-287-16670","dirk.skowasch@ukbonn.de",{"name":83,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":88,"status":37,"city":89,"state":18,"zip":90,"country":40,"countryCode":41,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Pneumologische Universitätsklinik Ruhrlandklinik","Essen","4542329",{"type":43,"coordinates":92},[93,94],7.01228,51.45657,{"lat":94,"lon":93},[97,101],{"name":98,"role":27,"phone":99,"phoneExt":18,"email":100},"Rüdiger Karpf-Wissel, Dr.","0049 201\u002F 433 4222","Ruediger.Karpf-Wissel@rlk.uk-essen.de",{"name":98,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":103,"status":37,"city":104,"state":18,"zip":105,"country":40,"countryCode":41,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Universitätsklinikum Halle (Saale)","Halle","06120",{"type":43,"coordinates":107},[108,109],11.97947,51.48158,{"lat":109,"lon":108},[112,116],{"name":113,"role":27,"phone":114,"phoneExt":18,"email":115},"Stephan Eisenmann, Dr.","+49 345 5573238","stephan.eisenmann@uk-halle.de",{"name":113,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":118,"status":37,"city":119,"state":18,"zip":120,"country":40,"countryCode":41,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Thoraxklinik University of Heidelberg","Heidelberg","69126",{"type":43,"coordinates":122},[123,124],8.69079,49.40768,{"lat":124,"lon":123},[127,129],{"name":128,"role":27,"phone":28,"phoneExt":18,"email":29},"Felix Herth, Prof. Dr.",{"name":128,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":131,"status":37,"city":132,"state":18,"zip":133,"country":40,"countryCode":41,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Lungenklinik Hemer","Hemer","58675",{"type":43,"coordinates":135},[136,137],7.77019,51.38707,{"lat":137,"lon":136},[140,144,148],{"name":141,"role":27,"phone":142,"phoneExt":18,"email":143},"Kaid Darwiche, Prof. Dr.","+49 2372 908 2179","kaid.darwiche@lkhemer.de",{"name":145,"role":27,"phone":146,"phoneExt":18,"email":147},"Birte Schwarz","+49 2372-908-2179","Birte.Schwarz@lkhemer.de",{"name":141,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":150,"status":37,"city":151,"state":18,"zip":152,"country":40,"countryCode":41,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Lungenfachklinik Immenhausen","Immenhausen","34376",{"type":43,"coordinates":154},[155,156],9.48017,51.42763,{"lat":156,"lon":155},[159,163],{"name":160,"role":27,"phone":161,"phoneExt":18,"email":162},"Peter Hammerl, Dr. med.","+49 5673 501 1501","hammerl@lungenfachklinik-immenhausen.de",{"name":160,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":165,"status":73,"city":166,"state":18,"zip":167,"country":40,"countryCode":41,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Asklepios Klinik Langen, Klinik für Innere Medizin III","Langen","63225",{"type":43,"coordinates":169},[170,171],8.66852,49.98955,{"lat":171,"lon":170},[174,178,181],{"name":175,"role":27,"phone":176,"phoneExt":18,"email":177},"Michael Bender, Dr. med.","+49 6103 912 61480","mi.bender@asklepios.com",{"name":179,"role":27,"phone":18,"phoneExt":18,"email":180},"Thorsten Stein, Dr. med.","th.stein@asklepios.com",{"name":175,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":183,"status":37,"city":184,"state":18,"zip":185,"country":40,"countryCode":41,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"KlinKlinikuim Lüdenscheid, Klinik für Pneumologie, internistische Intensivmedizin, Infektiologie und Schlafmedizin","Lüdenscheid","58515",{"type":43,"coordinates":187},[188,189],7.6273,51.21977,{"lat":189,"lon":188},[192,196],{"name":193,"role":27,"phone":194,"phoneExt":18,"email":195},"Wolfgang Hohenforst-Schmidt, Dr. med.","+49 2351 46-66225","pneumologie@klinikum-luedenscheid.de",{"name":193,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":198,"status":37,"city":199,"state":18,"zip":200,"country":40,"countryCode":41,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Thoraxzentrum Bezirk Unterfranken","Münnerstadt","97702",{"type":43,"coordinates":202},[203,204],10.20187,50.24636,{"lat":204,"lon":203},[207,211],{"name":208,"role":27,"phone":209,"phoneExt":18,"email":210},"Bernd Seese, Dr.","0049 9733\u002F62-3700","b.seese@tzbu.de",{"name":208,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":213,"status":37,"city":214,"state":18,"zip":215,"country":40,"countryCode":41,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Helios Hanseklinikum Stralsund","Stralsund","18435",{"type":43,"coordinates":217},[218,219],13.0818,54.30911,{"lat":219,"lon":218},[222,226],{"name":223,"role":27,"phone":224,"phoneExt":18,"email":225},"Tom Bollmann, Dr. med.","+49 3831352588","tom.bollmann@helios-gesundheit.de",{"name":223,"role":55,"phone":18,"phoneExt":18,"email":18},{"type":228,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100494362","bento---bronchoscopic-lung-volume-reduction-in-severe-emphysema-using-thermoablation-100494362",false,"NCT05717192","BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation","Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation","Inclusion Criteria:\n\n* Age: ≥ 40 years and ≤ 75 years\n* Written informed consent obtained from the patient\n* Severe emphysema with indication for BTVA:\n* bilateral heterogeneous emphysema of the upper lobes in GOLD stage 3\u002F4 and\n* evidence of severe emphysema in high-resolution computed tomography (not older than 6 months prior to inclusion) and\n* functional evidence of severe pulmonary hyperinflation and\n* FEV1 post lysis between 20% and \\\u003C 45% (calculated) and\n* Total lung capacity (TLC) ≥ 100% (calculated) and\n* Residual volume (RV) \\> 175% (calculated) and\n* arterial blood gas values of: PaCO2 ≤ 50 mmHg; PaO2 \\> 50 mmHg on room air and\n* marked dyspnoea with a score ≥ 2 on the Medical Research Council modified scale (mMRC) and\n* 6-minute walk test \\> 140 metres\n* Patient-specific, pre-interventional exhaustion of conservative treatment options\n* optimised medical therapy (according to the GOLD guidelines) and\n* Non-smoker for 6 months prior to inclusion\n* Evidence of completed pulmonary and geriatric rehabilitation in the last 4 years\n* ≥ 6 weeks outpatient or\n* ≥ 3 weeks inpatient or\n* Individual Participation in regular physical activities that go beyond the activities of daily living (e.g. a walking programme)\n* According to the investigator's assessment mentally and physically able to participate in the study procedures and visits\n* Indication within the framework of an interdisciplinary case conference with specialists in pneumology, radiology and thoracic surgery in accordance with §3 of the guideline on quality assurance measures in accordance with § 136 Paragraph 1 Sentence 1 Number 2 SGB V for inpatient care with bronchoscopic lung volume reduction procedures for severe emphysema (QS-RL BLVR).\n\nExclusion Criteria:\n\n* Any condition that would interfere with the conduct of the clinical trial follow-up or bronchoscopy or affect the outcome of the clinical trial\n* DLCO \\\u003C 20% (calculated)\n* Body mass index (BMI) \\\u003C 18 kg\u002Fm2 or \\> 32 kg\u002Fm2\n* Pulmonary hypertension\n* Peak systolic PAP \\> 45 mmHg or mean PAP \\> 25 mmHg\n* Right heart catheter measurements are considered authoritative over echocardiogram measurements\n* Clinically significant bronchiectasis\n* Pneumothorax or pleural effusions within the last 6 months\n* Heart and\u002For lung transplantation, surgical lung volume reduction (LVRS), bullectomy, lobectomy or pneumonectomy, pleurodesis or any surgery in the target lobes (upper lobes).\n* Recent respiratory infection or COPD exacerbation in the last 6 weeks\n* Unstable COPD (any of the following conditions):\n* \\>3 COPD-related hospitalisations requiring antibiotics in the last 12 months\n* COPD-related hospital stay in the last 3 months\n* daily use of systemic steroids, \\> 5 mg prednisolone\n* Single large bulla (defined as \\> 1\u002F3 of the volume of the lobe) in the upper lobe or paraseptal emphysema distribution in the lobe being treated\n* Coagulopathy or current use of anticoagulants\n* Patients with current endobronchial valves or with valves explanted less than 6 months ago in the target lobe in a segment to be treated with InterVapor®.\n* Patients with implanted, endobronchial coils (coils)\n* Patients with previous endobronchial polymer\u002Fadhesive treatment\n* Patients with immune system disorders or concomitant diseases that necessitate the use of immunosuppressants of clinical relevance\n* History of any of the following conditions:\n* Myocardial infarction or acute coronary syndrome in the previous year\n* Hospitalisation for left heart failure in the last year\n* clinically leading asthma disease or alpha-1-antitrypsin deficiency\n* Known sensitivity to medications required to perform bronchoscopy\n* Life expectancy \\\u003C 12 months\n* Newly prescribed morphine derivatives within the last 4 weeks\n* Pregnancy at the time of inclusion","ALL","40 Years","75 Years",{"count":240,"type":241},224,"ESTIMATED","INTERVENTIONAL",[244],"NA","Prospective, 2-arm, randomised (2:1), multicentre, open-label clinical trial in patients with severe emphysema. The intervention arm will be treated with Bronchoscopic lung volume reduction in severe emphysema using thermoablation.The interventional treatment (bronchoscopic lung volume reduction) is compared with the usual conservative standard therapy (GOLD guidelines).",[247],"Emphysema or Chronic Obstructive Pulmonary Disease","2025-08-19",{"date":250,"type":251},"2025-08-24","ACTUAL",{"date":253,"type":251},"2024-04-24",{"date":255,"type":241},"2027-12-01",{"name":5,"class":6},12]