NCT07156669

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)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Xenios AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2027-07-01
• First posted: 2025-09-05
• Last updated: 2026-04-13

Locations

2 sites across 1 country: Germany