RecruitingOBSERVATIONAL

A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System:The MOBYBOX Trial

This study, called MOBYBOX, is checking a special machine called the MOBYBOX System. This machine helps people whose heart or lungs aren't working properly because of serious conditions like heart or breathing failure. Doctors use it to either support the heart and lungs together (veno-arterial) or just the lungs (veno-venous) when other treatments aren't enough. The main goal is to see how safe the MOBYBOX machine is and how well it performs for patients in everyday hospital care. This type of study helps make sure medical devices are working as they should after they've been made available for use.

At a glance

Status

Recruiting

Sponsor

Hemovent GmbH

Enrolment target

Start

30 Apr 2024

Estimated completion

01 Dec 2026

Cardiac Failure Respiratory Failure Cardio-Respiratory Failure Imminent Cardiorespiratory or Respiratory Failure

What is this study about?

Imagine your heart or lungs are struggling so much that they can’t properly give your body the oxygen and blood it needs. This can be a very serious situation. The MOBYBOX System is a special kind of life support machine, similar to something called ECMO (Extracorporeal Membrane Oxygenation). It works by taking blood out of your body, adding oxygen, removing carbon dioxide, and then returning it to you. This gives your heart and lungs a chance to rest and recover.

This particular study, named MOBYBOX, isn't testing a brand-new treatment. Instead, it's a 'post-market surveillance' study. This means the MOBYBOX system is already approved and being used in hospitals. The study's main purpose is to carefully watch and collect information from patients who are already receiving this treatment. Doctors want to understand its safety and how effectively it helps people in normal, day-to-day medical care.

The information gathered from this study is really important. It helps doctors and medical device makers confirm that the MOBYBOX System is working reliably and safely for patients who need it most. It also helps them learn more about who benefits most from the system and how to use it best, ensuring that patients receive the highest standard of care.

Key takeaways

This study is checking how safe and effective a machine called the MOBYBOX System is for people with serious heart or lung problems.
The MOBYBOX System is already being used in hospitals; this study is observing its performance in real patients.
It helps either your lungs alone, or both your heart and lungs, when they're struggling.
You won't have extra tests for this study; it's about observing your care.
Doctors want to make sure the machine continues to work well and is safe for patients.

Who may be eligible?

To be considered for this study, you would typically be an adult between 18 and 80 years old, experiencing significant heart or lung failure, or at immediate risk of it. This includes situations where your breathing is very difficult, your oxygen levels are dangerously low, or your heart isn't pumping enough blood, and other treatments haven't been successful.

However, there are certain reasons why someone wouldn't be able to join. For example, if you've already been on similar life support for more than 48 hours, or if you have severe bleeding in the brain, or issues that make blood thinners unsafe. Very high body weight (over 180 kg), severe irreversible brain damage, or inability to accept blood transfusions would also prevent participation.

Specific heart or lung conditions also matter. For example, very high blood pressure in the lungs or severe heart weakness might make you unable to receive lung support, while certain issues with the main artery from the heart could prevent heart support. The healthcare team will carefully check all these factors to see if the MOBYBOX System is suitable and safe for you.

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 between 18 and 80 years old?
Do you have severe heart or breathing issues, or are you at risk of them?
Could you potentially need the MOBYBOX machine to help your heart or lungs?
Do you have any severe bleeding in the brain or other issues that prevent blood thinners?
Are you able to receive blood transfusions if needed?
Do you weigh less than 180 kg?

Answer every question to see your result.

What does participation involve?

This study mainly involves observing and collecting information from patients who are already receiving the MOBYBOX System as part of their standard medical care. There won't be any extra tests or procedures specifically for this study that aren't already part of your usual treatment. The medical team will keep track of how the system is working for you, your overall health, and any changes. The total duration of your involvement would depend on how long you need the MOBYBOX System, which your medical team will discuss with you. You would continue to receive all necessary care from your healthcare providers.

Potential risks and benefits

The main benefit for participants is receiving a proven medical device, the MOBYBOX System, which helps support your heart or lungs during a critical illness when other treatments aren't enough. As with any serious medical treatment, there are potential risks, which your doctors will explain in full. These are generally associated with the underlying severe illness and the use of life support systems, such as bleeding or infection. You always have the right to withdraw your consent to be part of the study at any time, without affecting the quality of your medical care.

Locations (4)

Medizinische Hochschule Hannover
Verified postcode
Hanover, Germany· Recruiting
Universitätsklinikum Essen
Verified postcode
Essen, Germany· Recruiting
Universitätsklinikum Halle
Verified postcode
Halle, Germany· Recruiting
Helios Klinikum Erfurt
Verified postcode
Erfurt, Germany· Recruiting

Common questions

What is the MOBYBOX System?

It's a special machine that takes over some of the work of your heart or lungs, helping add oxygen to your blood and remove waste, giving your own organs a chance to rest and heal.

Is the MOBYBOX System a new, experimental treatment?

No, this study is looking at a system that is already approved and used in hospitals. The study is gathering more information on its safety and how well it performs in real-world conditions.

What will I have to do if I join this study?

You won't have any extra treatments or tests just for the study. It involves your medical team collecting information about how the MOBYBOX System is helping you as part of your normal care.

Can I leave the study if I change my mind?

Yes, you can decide to stop being part of the study at any point. Your medical care will not be affected by this decision.

Who is funding this study?

The information provided doesn't specify the exact funding source, but typically, post-market studies like this are supported by the company that makes the medical device.

How to find out more

Yvonne Seibt

yseibt@hemovent.com +49 174 1773839 Official trial record

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