Safety and performance of the Novalung kit and Xenios 2.0 during stationary use for patients on ECMO

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational PMCF study evaluates the safety and performance of the Novalung ultimate kit in combination with Xenios 2.0 for adults on ECMO. It examines gas exchange outcomes during stationary hospital use and during ground-based transport. Devices will be used according to their intended purpose and local standards. Data will be collected under real-world clinical conditions across multiple sites. No intervention beyond routine clinical care is mandated by the study.

Why it matters

Who can join: the full rules

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

Where it's running

• Helios Klinikum Erfurt
  Erfurt, Bavaria, Germany Recruiting
• University Hospital Aachen
  Aachen, Germany Recruiting
• Krankenhaus Bethanien gGmbH
  Solingen, Germany Recruiting

Study contacts

• Principal investigator: Magdalena Römmer, Dr. med. — HELIOS Hospital, Erfurt, Germany
• Study coordinator: Anja Derlet-Savoia, Dr.
• Email: Anja.Derlet@freseniusmedicalcare.com
• Phone: +49 6172 268 6648

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MiniLung petite kit for neonates and infants with severe respiratory or cardiac failure

  We will test whether the MiniLung petite kit with the Xenios console safely improves oxygenation, removes CO2, and stabilizes circulation in newborns and young infants (2–8 kg) with severe respiratory or cardiopulmonary failure.

  Recruiting at 2 sites Fresenius Medical Care Deutschland GmbH · Bonn, North Rhine-Westphalia and 1 other locations · NCT06750536

• See if 18F-FAPI-74 PET/CT can better detect fibrosis in heart and lung disease

  Researchers are testing a new PET/CT tracer, 18F-FAPI-74, to see if it can reveal early fibrotic changes in people with heart and lung diseases who are at risk for tissue scarring.

  Recruiting Phase 3 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07613099

• Using near apneic ventilation with ECMO for severe respiratory distress

  This study is testing if a new way of breathing support called near apneic ventilation can help patients with severe respiratory distress on ECMO recover better and faster than the usual care.

  Recruiting at 11 sites Phase 3 Assistance Publique - Hôpitaux de Paris · Bobigny and 10 other locations · NCT06814340

• Using cangrelor to improve outcomes in patients with cardiogenic shock on ECMO

  This study is testing if adding a medication called cangrelor can help patients in cardiogenic shock on ECMO have better outcomes while reducing bleeding risks during their treatment.

  Recruiting Phase 2 IRCCS San Raffaele · Milan, Italy · NCT06792643

• Investigating left ventricle unloading during extracorporeal life support

  This study looks at how different methods of relieving pressure on the heart can help patients on a special life support system called VA ECLS, especially those in serious heart trouble.

  Recruiting Maastricht University Medical Center · Maastricht · NCT06766006

• RECOMMEND platform testing interventions for adults receiving ECMO

  This platform tests whether different treatments, such as liberal versus restrictive red blood cell transfusion strategies, help adults on ECMO survive and need less organ support and hospital resources by day 28.

  Recruiting Phase 3 Australian and New Zealand Intensive Care Research Centre · Camperdown, New South Wales and 2 other locations · NCT06526533

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.