Not yet recruitingOBSERVATIONAL

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)

This study is investigating new equipment used for very sick patients who need help with their heart and lungs. This support is called ECMO (Extracorporeal Membrane Oxygenation). The equipment includes the Novalung Ultimate Kit and the Xenios 2.0 system, which can also be used with a special transport unit called the MultiSupport Ground. Researchers want to see how safe and effective these machines are when used in the hospital and when patients are moved from one place to another. The main goal is to check if using this equipment helps keep the patient’s blood oxygen levels stable and improves their breathing. This is an observational study, meaning doctors will simply observe how the equipment works in real-life situations.

At a glance

Status

Not yet recruiting

Sponsor

Xenios AG

Enrolment target

Start

01 Apr 2026

Estimated completion

01 Jul 2027

Cardio-Respiratory Failure Extracorporeal Membrane Oxygenation Complication Acute Lung Injury

What is this study about?

When someone is very, very ill and their lungs or heart aren't working properly, they might need extra support from special machines to help them breathe and get enough oxygen into their blood. This kind of life support is often called ECMO. This study is looking at how well some newer versions of these machines work. Specifically, it's focusing on a system called the Novalung Ultimate Kit combined with another machine called the Xenios 2.0. Sometimes, patients who are on these machines need to be moved, for example, from one hospital ward to another, or even to a different hospital. This study also looks at how safe and effective this equipment is when used during ground transport with a special unit called the MultiSupport Ground.

The main aim is to see if using these kits helps keep the patient's blood oxygen at the right level and improves their overall breathing support. The doctors involved will be watching very carefully to make sure the equipment is working as it should and that it's safe for the patients. The machines are already approved for use, and this study is about understanding their performance better in real-world settings, both in the hospital and during transport.

By carefully observing how these machines work, doctors hope to gain more information about their safety and effectiveness. This will help them understand how best to use this technology to provide the best possible care for patients with severe heart and lung problems. This isn't a study where you get a new or untested treatment; it's about observing how existing, approved medical devices perform.

Key takeaways

The study observes how safe and effective two life support machines (Novalung and Xenios 2.0) are.
It helps doctors understand how these machines work for very sick patients in hospital and during transport.
The main goal is to check if the machines help keep blood oxygen levels stable.
These are existing, approved medical devices, not experimental treatments.
Participation involves observation only, with no changes to your medical care.
Information from this study could improve care for future patients with serious heart and lung conditions.

Who may be eligible?

This study is looking for adult patients who are already receiving life support called ECMO using the Novalung ultimate kit and the Xenios 2.0. This means you would already be using this specific equipment because of a serious heart or lung condition. If you need to be moved while on this support, and the MultiSupport Ground unit is used, that also fits the study's focus.

To join, you or a legal representative would need to give your permission by signing a consent form. In an emergency, a senior doctor might give permission if you're too unwell to do so yourself, ensuring treatment isn't delayed.

You would not be able to join if you are already taking part in another study that might affect the results of this one, or if you have been part of this exact study before. Also, if your ECMO treatment started somewhere other than the hospital taking part in this study, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult patient (18 years or older)?
Are you currently receiving ECMO support using the Novalung ultimate kit and Xenios 2.0?
Are you able to give permission, or can your legal representative do so?
Are you not currently in another study that might affect these results?
Did your ECMO treatment start at the hospital involved in this study?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, your participation will mainly involve doctors observing how the Novalung and Xenios 2.0 machines work while you are already receiving this life support. This is an 'observational' study, meaning you won't be given any new or additional treatments just for the study. Doctors will simply collect information about the machine’s performance and your blood oxygen levels as part of your routine care. Your medical team will continue to make all decisions about your treatment as usual. There are no extra hospital visits or special appointments required specifically for the study. The study duration for each patient would be for as long as you are receiving the ECMO treatment with these specific devices.

Potential risks and benefits

The potential benefit of taking part is that the information gathered from your care could help doctors better understand how to use these life support machines most effectively for future patients, potentially improving care for others. As these devices are already part of standard medical care for very sick patients, taking part in this observational study does not involve any additional medical risks beyond those already associated with your critical condition and the ECMO treatment itself. You are always free to withdraw from the study at any time without your medical care being affected.

Locations (2)

University Hospital Aachen
Verified postcode
Aachen, Germany
Krankenhaus Bethanien gGmbH
Verified postcode
Solingen, Germany

Common questions

What is ECMO?

ECMO (Extracorporeal Membrane Oxygenation) is a life support treatment that helps your heart and lungs when they are too sick to work on their own.

Are the devices in this study new or experimental?

No, the Novalung and Xenios 2.0 devices are already approved and being used in hospitals for patients needing heart and lung support. This study is observing how well they perform.

Will I receive any new medicines for this study?

No, this study only observes how existing medical devices work. You won't be given any new treatments or medicines specifically for the study.

Will taking part change my medical care?

Your medical team will continue to provide you with the best possible care based on your condition. Taking part in this study will not change your treatment plan.

How long will I be in the study?

You would be part of the study for as long as you are receiving the heart and lung support using these specific machines.

How to find out more

Anja Derlet-Savoia, Dr.

anja.derlet@freseniusmedicalcare.com +49 6172 268 6648 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.