[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604988":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":64,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":10,"enrollmentInfo":78,"targetDuration":10,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":90,"whyStopped":10,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},{"fullName":5,"class":6},"Fresenius Medical Care Deutschland GmbH","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Extracorporeal Life Support (ECLS)",null,"Patients who receive ECLS treatment and require a ground-based inter- hospital patient transport and\u002F or stationary treatment on ECMO",[13],"Device: Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG)","Patients will receive ECLS treatment using the Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG) during ground-based inter-hospital patient transport and\u002F or stationary treatment according to their intended use and local standards\u002F requirements.",[9],[21],{"name":22,"affiliation":23,"role":24},"Heinrich Groesdonk, Prof. Dr. med.","HELIOS Hospital, Erfurt, Germany","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Anja Derlet-Savoia, Dr.","CONTACT","+49 6172 268 6648","Anja.Derlet@freseniusmedicalcare.com",{"name":32,"role":28,"phone":10,"phoneExt":10,"email":33},"Fiona Bellando","fiona.bellando@freseniusmedicalcare.com",[35,51],{"facility":36,"status":10,"city":37,"state":10,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"University Hospital Aachen","Aachen","52074","Germany","DE",{"type":42,"coordinates":43},"Point",[44,45],6.08342,50.77664,{"lat":45,"lon":44},[48],{"name":49,"role":28,"phone":10,"phoneExt":10,"email":50},"Alexander Kersten, Dr. med.","akersten@ukaachen.de",{"facility":52,"status":10,"city":53,"state":10,"zip":54,"country":39,"countryCode":40,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Krankenhaus Bethanien gGmbH","Solingen","42699",{"type":42,"coordinates":56},[57,58],7.0845,51.17343,{"lat":58,"lon":57},[61],{"name":62,"role":28,"phone":10,"phoneExt":10,"email":63},"Winfried J. Randerath, Prof Dr med","randerath@klinik-bethanien.de",{"type":65,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[67],{"name":68,"class":6},"Alcedis GmbH","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":79,"type":80},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.",[84,85,86],"Cardio-Respiratory Failure","Extracorporeal Membrane Oxygenation Complication","Acute Lung Injury",[88,89],"Extracorporeal Life Support","Extracorporeal Membrane Oxygenation","NOT_YET_RECRUITING","2026-04-08",{"date":93,"type":94},"2026-04-13","ACTUAL",{"date":96,"type":80},"2026-04",{"date":98,"type":80},"2027-07",{"name":100,"class":6},"Xenios AG",2]