Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT07156669
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-06-05', 'studyFirstSubmitQcDate': '2025-09-02', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arterial oxygen saturation (SaO2) [%]', 'timeFrame': 'Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days', 'description': 'Longitudinal assessments of continuous outcomes will be analyzed by treatment day using mixed models for repeated measures (MMRM), with ECMO mode as a fixed factor (except for analyses performed within the subsets defined by ECMO mode) and the baseline value of the primary endpoint as a covariate.\n\nWithin-subject differences between baseline and subsequent visits will be tested using contrasts. The comparison between baseline and the first day on ECMO (initial effect) is considered as the primary outcome.'}], 'secondaryOutcomes': [{'measure': 'Performance objective Cardiacirculation', 'timeFrame': 'Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days', 'description': "Improvement and maintenance of patients' cardiocirculation in patients transported and treated stationary on ECMO"}, {'measure': 'Performance objective Maintenance of blood flow', 'timeFrame': 'Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days', 'description': 'Evaluation of Xenios 2.0 performance during transport and stationary use: Maintenance of blood flow (L/min)'}, {'measure': 'Performance objective Pump speed', 'timeFrame': 'Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days', 'description': 'Evaluation of Xenios 2.0 performance during transport and stationary use: Pump speed (rpm)'}, {'measure': 'Performance objective Circuit pressures', 'timeFrame': 'Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days', 'description': 'Evaluation of Xenios 2.0 performance during transport and stationary use: Circuit pressures (mmHg)'}, {'measure': 'Safety objectives', 'timeFrame': 'Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days', 'description': 'Assessment of the safety of the use of the Xenios System for ground-based transport and stationary use of patients on ECMO.\n\nComplications will be grouped in device-, transport-, cannula-, and patient-related complications and presented as relative and absolute frequencies.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extracorporeal Life Support', 'Extracorporeal Membrane Oxygenation'], 'conditions': ['Cardio-Respiratory Failure', 'Extracorporeal Membrane Oxygenation Complication', 'Acute Lung Injury']}, 'descriptionModule': {'briefSummary': '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/ requirements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with severe acute respiratory and/or cardiopulmonary failure treated on ECMO.', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07156669', 'acronym': 'Transport+', 'briefTitle': '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)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Medical Care Deutschland GmbH'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'HL-ECMO-01-INT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Extracorporeal Life Support (ECLS)', 'description': 'Patients who receive ECLS treatment and require a ground-based inter- hospital patient transport and/ or stationary treatment on ECMO', 'interventionNames': ['Device: Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG)']}], 'interventions': [{'name': 'Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG)', 'type': 'DEVICE', 'description': '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/ or stationary treatment according to their intended use and local standards/ requirements.', 'armGroupLabels': ['Extracorporeal Life Support (ECLS)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Anja Derlet-Savoia, Dr.', 'role': 'CONTACT', 'email': 'Anja.Derlet@freseniusmedicalcare.com', 'phone': '+49 6172 268 6648'}, {'name': 'Fiona Bellando', 'role': 'CONTACT', 'email': 'fiona.bellando@freseniusmedicalcare.com'}], 'overallOfficials': [{'name': 'Heinrich Groesdonk, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HELIOS Hospital, Erfurt, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xenios AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Alcedis GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}