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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)

Recruitingn/aAges 18 Years - anyAllXenios AG
NCT07156669 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Informed consent signed and dated by the attending physician; and 1. If patient is able to give consent: by the study patient 2. If patient is unable to give consent: by the legal representative or 3. If an emergency situation is determined: by a consultant physician Exclusion Criteria: * Participation in any interventional clinical study that could impact the results of this prospective, observational PMCF study * Previous participation in the same study * ECMO cannulation outside the referring or trial site hospital
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What it tests

  • Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG)
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Where

3 sites
Helios Klinikum Erfurt
Erfurt, Germany
University Hospital Aachen
Aachen, Germany
Krankenhaus Bethanien gGmbH
Solingen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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