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) (Transport+)

April 8, 2026 updated by: Xenios AG
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with severe acute respiratory and/or cardiopulmonary failure treated on ECMO.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Extracorporeal Life Support (ECLS)
Patients who receive ECLS treatment and require a ground-based inter- hospital patient transport and/ or stationary treatment on ECMO
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial oxygen saturation (SaO2) [%]
Time Frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days

Longitudinal assessments of continuous outcomes will be analyzed by treatment day using mixed models for repeated measures (MMRM), with ECMO mode as a fixed factor (except for analyses performed within the subsets defined by ECMO mode) and the baseline value of the primary endpoint as a covariate.

Within-subject differences between baseline and subsequent visits will be tested using contrasts. The comparison between baseline and the first day on ECMO (initial effect) is considered as the primary outcome.
Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance objective Cardiacirculation
Time Frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Improvement and maintenance of patients' cardiocirculation in patients transported and treated stationary on ECMO
Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Performance objective Maintenance of blood flow
Time Frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Evaluation of Xenios 2.0 performance during transport and stationary use: Maintenance of blood flow (L/min)
Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Performance objective Pump speed
Time Frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Evaluation of Xenios 2.0 performance during transport and stationary use: Pump speed (rpm)
Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Performance objective Circuit pressures
Time Frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Evaluation of Xenios 2.0 performance during transport and stationary use: Circuit pressures (mmHg)
Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Safety objectives
Time Frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days

Assessment of the safety of the use of the Xenios System for ground-based transport and stationary use of patients on ECMO.

Complications will be grouped in device-, transport-, cannula-, and patient-related complications and presented as relative and absolute frequencies.
Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xenios AG

Collaborators

Alcedis GmbH

Investigators

  • Principal Investigator: Heinrich Groesdonk, Prof. Dr. med., HELIOS Hospital, Erfurt, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

June 5, 2025

First Submitted That Met QC Criteria

September 2, 2025

First Posted (Actual)

September 5, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL-ECMO-01-INT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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