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)
| NCT ID | NCT07156669 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xenios AG |
| Condition | Cardio-Respiratory Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-05-19 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2026-05-19 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Magdalena Römmer, Dr. med.
PRINCIPAL INVESTIGATOR
HELIOS Hospital, Erfurt, Germany
Frequently Asked Questions
Who can join the NCT07156669 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardio-Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07156669 currently recruiting?
Yes, NCT07156669 is actively recruiting participants. Contact the research team at Anja.Derlet@freseniusmedicalcare.com for enrollment information.
Where is the NCT07156669 trial being conducted?
This trial is being conducted at Erfurt, Germany, Aachen, Germany, Solingen, Germany.
Who is sponsoring the NCT07156669 clinical trial?
NCT07156669 is sponsored by Xenios AG. The principal investigator is Magdalena Römmer, Dr. med. at HELIOS Hospital, Erfurt, Germany. The trial plans to enroll 20 participants.