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)

ClinicalTrials.gov ID

NCT07156669

Lead Sponsor

Xenios AGINDUSTRY

Overall Status

Recruiting

Study Type

Observational

Enrollment

20Estimated

Last Update Posted

Sep 4, 2026Actual

Start Date

May 19, 2026Actual

Primary Completion Date

Apr 2027Estimated

Completion Date

Jul 2027Estimated

Official Title

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)

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 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.

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

• Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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

  1. If patient is able to give consent: by the study patient
  2. If patient is unable to give consent: by the legal representative or
  3. If an emergency situation is determined: by a consultant physician

Exclusion Criteria:

• 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

Observational Model

Other

Time Perspective

Prospective

Lead Sponsor

Xenios AGINDUSTRY

Collaborators

Alcedis GmbHINDUSTRY

akersten@ukaachen.de

randerath@klinik-bethanien.de

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