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)

Not yet recruiting

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

• Registration Number: NCT07156669
• Lead Sponsor: Xenios AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-05
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Study Start: 2025-10-01
• Primary Completion: 2026-10
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arterial oxygen saturation (SaO2) [%]	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.

Secondary Outcome Measures

Name	Time	Method
Performance objective Cardiacirculation	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
Performance objective Maintenance of blood flow	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)
Performance objective Pump speed	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)
Performance objective Circuit pressures	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)
Safety objectives	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.