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+)

Xenios

Status

Not yet enrolling

Conditions

Extracorporeal Membrane Oxygenation Complication

Acute Lung Injury

Cardio-Respiratory Failure

Treatments

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

Study type

Observational

Funder types

Industry

Identifiers

NCT07156669

HL-ECMO-01-INT

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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