RecruitingNCT07156669

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

Enrollment

20 participants

Start Date

May 19, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG) for people with acute lung injury, cardio-respiratory failure, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENovalung 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.


Locations(3)

Helios Klinikum Erfurt

Erfurt, Bavaria, Germany

University Hospital Aachen

Aachen, Germany

Krankenhaus Bethanien gGmbH

Solingen, Germany

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NCT07156669


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