[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100376602":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":24,"responsibleParty":110,"collaborators":112,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":7,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":129,"studyType":130,"phases":7,"briefSummary":131,"conditions":132,"keywords":7,"overallStatus":27,"whyStopped":7,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Hemovent GmbH","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","MOBYBOX System","extracorporeal cardiopulmonary support",[14],{"name":15,"affiliation":16,"role":17},"Tienush Rassaf, Prof.","Uniklinikum Essen","PRINCIPAL_INVESTIGATOR",[19],{"name":20,"role":21,"phone":22,"phoneExt":7,"email":23},"Yvonne Seibt","CONTACT","+49 174 1773839","yseibt@hemovent.com",[25,49,71,89],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Medizinische Hochschule Hannover","RECRUITING","Hanover","Lower Saxony","30625","Germany","DE",{"type":34,"coordinates":35},"Point",[36,37],9.73322,52.37052,{"lat":37,"lon":36},[40,44,47],{"name":41,"role":21,"phone":42,"phoneExt":7,"email":43},"Christian Kühn, Professor","+49 511 532-0","Kuehn.Christian@mh-hannover.de",{"name":45,"role":46,"phone":7,"phoneExt":7,"email":7},"Heiko Schenk, MD","SUB_INVESTIGATOR",{"name":48,"role":46,"phone":7,"phoneExt":7,"email":7},"Olaf Wiesner, MD",{"facility":50,"status":27,"city":51,"state":52,"zip":53,"country":31,"countryCode":32,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Universitätsklinikum Essen","Essen","North Rhine-Westphalia","45147",{"type":34,"coordinates":55},[56,57],7.01228,51.45657,{"lat":57,"lon":56},[60,63,67,69],{"name":15,"role":21,"phone":61,"phoneExt":7,"email":62},"+49 201 723-4801","tienush.rassaf@uk-essen.de",{"name":64,"role":21,"phone":65,"phoneExt":7,"email":66},"Amir Abbas Mahabadi, Prof.","+49 201 723-84822","amir-abbas.mahabadi@uk-essen.de",{"name":68,"role":46,"phone":7,"phoneExt":7,"email":7},"Lars Michel, MD",{"name":70,"role":46,"phone":7,"phoneExt":7,"email":7},"Florian Schindhelm, MD",{"facility":72,"status":27,"city":73,"state":74,"zip":75,"country":31,"countryCode":32,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Universitätsklinikum Halle","Halle","Saxony-Anhalt","06120",{"type":34,"coordinates":77},[78,79],11.97947,51.48158,{"lat":79,"lon":78},[82,86,87],{"name":83,"role":21,"phone":84,"phoneExt":7,"email":85},"Alexander Vogt, MD","+49 3455572601","alexander.vogt@uk-halle.de",{"name":83,"role":17,"phone":7,"phoneExt":7,"email":7},{"name":88,"role":46,"phone":7,"phoneExt":7,"email":7},"Adrian Kirsten, Doctor",{"facility":90,"status":27,"city":91,"state":7,"zip":92,"country":31,"countryCode":32,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Helios Klinikum Erfurt","Erfurt","99089",{"type":34,"coordinates":94},[95,96],11.03536,50.97734,{"lat":96,"lon":95},[99,102,106,108],{"name":100,"role":21,"phone":7,"phoneExt":7,"email":101},"Heinrich Groesdonk, Professor","heinrich.groesdonk@helios-gesundheit.de",{"name":103,"role":21,"phone":104,"phoneExt":7,"email":105},"Magdalena Römmer, Doctor","+49 361 781-6075","magdalena.roemmer@helios-gesundheit.de",{"name":107,"role":46,"phone":7,"phoneExt":7,"email":7},"Klaus Matzen, MD",{"name":109,"role":46,"phone":7,"phoneExt":7,"email":7},"Udo Stelzer, MD",{"type":111,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[113],{"name":114,"class":115},"seleon GmbH","UNKNOWN","100376602","a-post-market-surveillance-study-of-the-hemovent-extracorporeal-cardiopulmonary-support-systemthe-mobybox-trial-100376602",false,"NCT04183660","A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System:The MOBYBOX Trial","A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System for Cardiac and Respiratory Support: The MOBYBOX Trial","Inclusion Criteria:\n\n* Diagnosed with cardiac, respiratory or cardiorespiratory failure or imminent failure and 1 of the 5 following sets of findings:\n\n  1. A Murray score ≥ 3.0 and\u002For severe hypoxemia with A PaO2\u002FFIO2 \\> 100 mm on 0.9 FIO2;\n  2. Uncompensated hypercapnia with pH \\\u003C7.2 despite a Pplateau \\> 30 cm H20;\n  3. Significant air leak\u002Fbronchopleural fistula;\n  4. Need for intubation in a patient on lung transplant list;\n  5. Immediate\u002Frisk of cardiac or respiratory collapse (pulmonary embolus, blocked airway, blocked blood flow, unresponsive to optimal care);\n* Written consent of the patient or the legal guardian or external consulting physician as designated and approved by the Ethics Committee.\n\nExclusion Criteria:\n\n* High pressure ventilation (FIO2 \\> 0.9 and Pplateau \\> 30 cm H2O) or high FIO2 requirements for more than 7 days;\n* Severe intracranial bleeding, which precludes the use of anticoagulation therapy or any other inability to be anticoagulated\n* Excessive weight (\\> 180 Kg)\n* Severe irreversible brain injury (e.g., hypoxic brain injury)\n* Inability to accept blood products;\n* Any condition or organ dysfunction that would limit the likelihood of overall benefit from ECMO, such as severe, irreversible brain injury, hepatic and\u002For renal failure, or untreatable metastatic cancer;\n* Immunosuppression with an absolute neutrophil count \\\u003C 400\u002Fmm3;\n* Patient has been treated with ECMO ≤ 48 hours.\n* For veno-veno ECMO in the setting of respiratory failure the following exclusion criteria apply:\n* Severe pulmonary hypertension (mPAP \\> 50 mm Hg)\n* Severe right or left sided heart failure (EF \\\u003C 25%)\n* For veno-arterial ECMO in the setting of cardiac insufficiency:\n* Severe aortic regurgitation\n* Aortic dissection.\n* The patient is moribund, or the patient has severe or deteriorating damage in critical body systems.\n* Patient is participating in an investigational drug or device study trial that has not reached the primary endpoint or that interferes with the current study endpoints.\n* Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.","ALL","18 Years","80 Years",{"count":127,"type":128},60,"ESTIMATED","30 Days","OBSERVATIONAL","The purpose of this study is to evaluate prospectively the safety and performance of the MOBYBOX System in the veno-arterial configuration in patients with cardiorespiratory failure or in the veno-venous configuration in patients with severe respiratory failure.",[133,134,135,136],"Cardiac Failure","Respiratory Failure","Cardio-Respiratory Failure","Imminent Cardiorespiratory or Respiratory Failure","2025-05-27",{"date":139,"type":140},"2025-05-31","ACTUAL",{"date":142,"type":140},"2024-04-30",{"date":144,"type":128},"2026-12",{"name":5,"class":6},4]