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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)
Sponsor: Xenios AG
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 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 Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
20
Start Date
2025-10
Completion Date
2027-04
Last Updated
2025-09-05
Healthy Volunteers
No
Conditions
Interventions
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/ or stationary treatment according to their intended use and local standards/ requirements.