[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardio-respiratory-failure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardio-respiratory-failure":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100604988","safety-and-performance-of-the-novalung-ultimate-kit-and-xenios-20-during-stationary-use-in-hospital-and-ground-based-transport-of-patients-on-extracorporeal-life-support-ecls-100604988",false,"NCT07156669","Safety and Performance of the Novalung Ultimate Kit and Xenios 2.0 During Stationary Use in Hospital and Ground-based Transport of Patients on Extracorporeal Life Support (ECLS)","Transport+","Inclusion Criteria:\n\n* Adult patients receiving an ECMO treatment with the Novalung ultimate kit in combination with the Xenios 2.0 (and the MultiSupport Ground during inter- and intra-hospital transport, if applicable) according to the intended use\n* Informed consent signed and dated by the attending physician; and\n\n  1. If patient is able to give consent: by the study patient\n  2. If patient is unable to give consent: by the legal representative or\n  3. If an emergency situation is determined: by a consultant physician\n\nExclusion Criteria:\n\n* Participation in any interventional clinical study that could impact the results of this prospective, observational PMCF study\n* Previous participation in the same study\n* ECMO cannulation outside the referring or trial site hospital","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","OBSERVATIONAL","This prospective observational study will evaluate the safety and performance of the Novalung ultimate kit in combination with the Xenios 2.0 and the MultiSupport Ground during stationary use in hospital and ground-based transport of patients treated on extracorporeal membrane oxygenation (ECMO). The primary objective is to assess whether the use of the medical devices improves and maintains the gas exchange (blood oxygenation) in these patients. Medical Devices will be used according to their intended purpose and local standards\u002F requirements.",[24,25,26],"Cardio-Respiratory Failure","Extracorporeal Membrane Oxygenation Complication","Acute Lung Injury",[28,29],"Extracorporeal Life Support","Extracorporeal Membrane Oxygenation","NOT_YET_RECRUITING","2026-04-08",{"date":33,"type":34},"2026-04-13","ACTUAL",{"date":36,"type":20},"2026-04",{"date":38,"type":20},"2027-07",{"name":40,"class":41},"Xenios AG","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":52,"studyType":21,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100376602","a-post-market-surveillance-study-of-the-hemovent-extracorporeal-cardiopulmonary-support-systemthe-mobybox-trial-100376602","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.","80 Years",{"count":51,"type":20},60,"30 Days","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.",[55,56,24,57],"Cardiac Failure","Respiratory Failure","Imminent Cardiorespiratory or Respiratory Failure","RECRUITING","2025-05-27",{"date":61,"type":34},"2025-05-31",{"date":63,"type":34},"2024-04-30",{"date":65,"type":20},"2026-12",{"name":67,"class":41},"Hemovent GmbH",4]