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)
Starting soon
Conditions studied: Cardio-Respiratory Failure, Extracorporeal Membrane Oxygenation Complication, Acute Lung Injury
In brief
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.
Key facts
- Study ID
- NCT07156669
- Run by
- Xenios AG
- People needed
- 20
- Starts
- 2026-04-01
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-04-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- If patient is able to give consent: by the study patient
- If patient is unable to give consent: by the legal representative or
- If an emergency situation is determined: by a consultant physician
You may not qualify if…
- 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
Where it is running
- University Hospital Aachen — Aachen, Germany
- Krankenhaus Bethanien gGmbH — Solingen, Germany
Full record on ClinicalTrials.gov
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