What is the MOBYBOX System studying for cardiac and respiratory failure?

The MOBYBOX System is being studied to evaluate its safety and performance in patients with cardiac, respiratory, or combined cardiorespiratory failure. Researchers aim to understand how well the device supports heart and lung function in critically ill patients. This study is sponsored by Hemovent GmbH to monitor the device in real clinical use.

Who may be eligible for this cardiac and respiratory failure clinical trial?

Adults between 18 and 80 years old diagnosed with cardiac, respiratory, or cardiorespiratory failure or at imminent risk may be eligible. Both men and women can participate. Certain health conditions like high pressure ventilation for over 7 days or severe bleeding that prevents blood thinning may exclude participants. Please review eligibility criteria for more details.

Is there any cost to participate in this cardiac and respiratory failure clinical trial?

Study-related care, including the use of the MOBYBOX device and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Age: 18Years - 80Years

All Genders

ID04183660

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

Led by Hemovent GmbH · Updated on 2025-05-31

Participants Needed

Research Sites

34 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and performance of the MOBYBOX System, an extracorporeal cardiopulmonary support device, in patients experiencing cardiac, respiratory, or combined cardiorespiratory failure. The study aims to gather prospective data on how well the device works and its safety profile in real-world use for patients with severe conditions affecting heart and lung function. The MOBYBOX System is used in two configurations veno-arterial for cardiac or cardiorespiratory failure and veno-venous for severe respiratory failure. The device provides extracorporeal support to help patients whose heart or lungs are failing. The study monitors device performance every 4 hours while patients are receiving extracorporeal membrane oxygenation ECMO with the MOBYBOX system and records serious adverse events within 24 hours. Participants will be closely observed during their treatment with the device, with assessments focusing on safety by tracking serious adverse events within 24 hours and mortality within 30 days. Device performance success is also recorded regularly during treatment. The study will continue to follow patients until December 2026, collecting data relevant to the devices safety and effectiveness in supporting heart and lung function in critically ill patients.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosed with cardiac, respiratory, or cardiorespiratory failure or imminent failure with one of the following: Murray score 63 3.0 and/or severe hypoxemia (PaO2/FIO2 > 100 mm on 0.9 FIO2)
Uncompensated hypercapnia with pH < 7.2 despite a plateau pressure > 30 cm H2O
Significant air leak or bronchopleural fistula
Need for intubation while on lung transplant list
Immediate risk of cardiac or respiratory collapse (e.g., pulmonary embolus, blocked airway, blocked blood flow, unresponsive to optimal care)
Written consent from patient, legal guardian, or designated external consulting physician approved by Ethics Committee
Age between 18 and 80 years

You will not qualify if you...

High pressure ventilation (FIO2 > 0.9 and plateau pressure > 30 cm H2O) or high FIO2 needs for more than 7 days
Severe intracranial bleeding preventing anticoagulation or inability to be anticoagulated
Weight over 180 kilograms
Severe irreversible brain injury (e.g., hypoxic brain injury)
Inability to accept blood products
Conditions limiting benefit from ECMO such as severe brain injury, liver or kidney failure, or untreatable metastatic cancer
Immunosuppression with absolute neutrophil count < 400/mm3
Previous ECMO treatment for 48 hours or less
For veno-venous ECMO: severe pulmonary hypertension (mPAP > 50 mm Hg), severe right or left heart failure (ejection fraction < 25%)
For veno-arterial ECMO: severe aortic regurgitation, aortic dissection
Moribund condition or severe damage in critical body systems
Participation in another investigational drug or device study that interferes with this study
Any condition that impairs informed consent, compliance, increases risk, or confounds study results

Research Team

Yvonne Seibt

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