RecruitingNCT04183660

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

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


Sponsor

Hemovent GmbH

Enrollment

60 participants

Start Date

Apr 30, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to evaluate prospectively the safety and performance of the MOBYBOX System in the veno-arterial configuration in patients with cardiorespiratory failure or in the veno-venous configuration in patients with severe respiratory failure.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This post-market study is monitoring the safety and outcomes of patients who use the Hemovent ECMO device — a machine that temporarily takes over the work of the heart and/or lungs for critically ill patients when these organs are failing. **You may be eligible if...** - You are experiencing severe heart failure, severe respiratory failure, or both - You meet specific clinical criteria showing your heart or lungs are unable to function adequately on their own (e.g., very low oxygen levels or dangerously high CO2) - You need urgent intubation or cardiac surgery **You may NOT be eligible if...** - You or your family refuse ECMO treatment - You have conditions that make ECMO inappropriate (as determined by your care team) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMOBYBOX System

extracorporeal cardiopulmonary support


Locations(4)

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Universitätsklinikum Halle

Halle, Saxony-Anhalt, Germany

Helios Klinikum Erfurt

Erfurt, Germany

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NCT04183660


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