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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)

NCT07156669 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Cardio-Respiratory Failure
  • Extracorporeal Membrane Oxygenation Complication
  • Acute Lung Injury

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Alcedis GmbH

    collaborator INDUSTRY

  • Xenios AG

    lead INDUSTRY

Principal Investigators

  • Heinrich Groesdonk, Prof. Dr. med. · HELIOS Hospital, Erfurt, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-04-30
Completion
2027-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07156669 on ClinicalTrials.gov