[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xenios AG\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":97},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,68],{"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":42},"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",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":42},"100573765","evaluating-the-safety-and-performance-of-the-minilung-petite-kit-in-neonatal-and-pediatric-patients-with-acute-respiratory-and-cardiac-failure-100573765","NCT06750536","Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure","PETIT","Inclusion criteria\n\n* Informed consent signed and dated by parents or legal representative and investigator\u002Fauthorized physician\n* Patients ≥2- ≤8 kg bodyweight to be treated with the MiniLung petite kit\n* Acute severe respiratory and\u002For cardiopulmonary failure with an ECMO indication\n\nExclusion criteria:\n\n* Participation in an interventional clinical study during the preceding 30 days that could interfere with the ECLS therapy\n* Previous participation in the same study\n* Prematurity (\\\u003C34 weeks gestational age)\n* Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT)\n* Impossibility of systemic anticoagulation","8 Months",{"count":19,"type":20},"This prospective observational study will evaluate the safety and performance of the MiniLung petite kit in neonatal and pediatric patients with acute respiratory and cardiac failure.\n\nThe main question it aims to answer is (study hypotheses):\n\nVeno-venous (VV) and veno-arterial (VA) Extracorporeal Membrane Oxygenation (ECMO) using the MiniLung petite kit is safe and improves gas exchange (oxygenation and CO2 removal) and hemodynamic stabilization in neonatal and pediatric patients with severe acute respiratory and\u002For cardiopulmonary failure within 24 hours compared to the treatment before VV or VA ECMO initiation and maintain a life-sustaining condition.",[25,54,55,26],"Neonatal Aspiration Pneumonia","Acute Respiratory Failure",[29,57,58],"Neonatal and pediatric patients","MiniLung petite kit","RECRUITING","2025-12-18",{"date":62,"type":34},"2025-12-24",{"date":64,"type":34},"2025-10-12",{"date":66,"type":20},"2026-12",{"name":40,"class":41},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":42},"100447442","efficacy-and-safety-of-synchronized-cardiac-support-in-cardiogenic-shock-patients-100447442","NCT05106491","Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients","Evaluating the Efficacy and Safety of the Synchronized Cardiac Support Treatment with the Icor Kit in Patients with Cardiogenic Shock - a Pivotal Study (Pulse SE)","PulseSE","Inclusion Criteria:\n\n1. Informed consent signed and dated by study patient\u002Flegal representative and investigator\u002Fauthorised physician\n2. Minimum age of 18 years\n3. Patients in cardiogenic shock\n4. Cardiogenic shock is defined as:\n\n   1. Systolic blood pressure \\\u003C 90 mmHg for at least 30 min\n   2. Inotropes and\u002For vasopressors are needed to maintain systolic blood pressure \\> 90 mmHg\n   3. Clinical signs of heart insufficiency with pulmonary congestion\n5. Signs of end organ hypoperfusion with at least one of the following criteria:\n\n   1. Cold, damp skin or extremities\n   2. Oliguria (≤ 30 mL\u002Fh)\n6. Serum lactate \\> 3.0 mmol\u002FL\n\nExclusion Criteria:\n\n1. In case of female patients: pregnancy or lactation period\n2. Participation in an interventional clinical study during the preceding 30 days\n3. Previous participation in the same study\n4. Age \\> 85 years\n5. Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) \\> 30 min\n6. No flow time \\> 5 min\n7. Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture)\n8. Non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.)\n9. Fever (Body temperature \\> 38.0 °C) or other evidence of sepsis\n10. Onset of cardiogenic shock \\> 6 h before enrolment\n11. Lactate \\> 16 mmol\u002FL\n12. Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters\n13. Contra-indications for anticoagulation\n14. Contra-indication for VA ECMO, e.g. unrecoverable heart and not a candidate for transplant or VAD","85 Years",{"count":78,"type":20},21,"INTERVENTIONAL",[81],"NA","The study aims to investigate the safety and efficacy of the Synchronized Cardiac Support treatment wit the icor kit and the Xenios console with modified sensor box ECG and Software Version 3.2.4",[84,29,85,86],"Cardiogenic Shock","ECLS","VA ECMO",[84,29,88,85,86],"Synchronized Cardiac Support","2025-03-13",{"date":91,"type":34},"2025-03-14",{"date":93,"type":20},"2025-09",{"date":95,"type":20},"2026-09",{"name":40,"class":41},""]