Status:
NOT_YET_RECRUITING
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)
Lead Sponsor:
Xenios AG
Collaborating Sponsors:
Alcedis GmbH
Conditions:
Cardio-Respiratory Failure
Extracorporeal Membrane Oxygenation Complication
Eligibility:
All Genders
18+ years
Brief Summary
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 hospi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07156669
Start Date
October 1 2025
End Date
April 1 2027
Last Update
September 5 2025
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