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 | Not Yet Recruiting

• 1 other identifier: HL-ECMO-01-INT
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Extracorporeal Life Support; Extracorporeal Membrane Oxygenation

Outcome Measures

Primary Outcomes (1)

• Arterial oxygen saturation (SaO2) [%]

  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 Outcomes (5)

• Performance objective Cardiacirculation

  Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days

• Performance objective Maintenance of blood flow

  Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days

• Performance objective Pump speed

  Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days

• Performance objective Circuit pressures

  Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days

• Safety objectives

  Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days

Study Arms (1)

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)

Interventions

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

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.

Extracorporeal Life Support (ECLS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xenios AG: lead
• Alcedis GmbH: collaborator

Study Sites (2)

University Hospital Aachen

Aachen, 52074, Germany

Location

Krankenhaus Bethanien gGmbH

Solingen, 42699, Germany

Location

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Heinrich Groesdonk, Prof. Dr. med.

  HELIOS Hospital, Erfurt, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anja Derlet-Savoia, Dr.

CONTACT

+49 6172 268 6648; Anja.Derlet@freseniusmedicalcare.com

Fiona Bellando

CONTACT

fiona.bellando@freseniusmedicalcare.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: September 5, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

DE (2)