Actively Recruiting
A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System:The MOBYBOX Trial
Led by Hemovent GmbH · Updated on 2025-05-31
60
Participants Needed
4
Research Sites
135 weeks
Total Duration
On this page
Sponsors
H
Hemovent GmbH
Lead Sponsor
S
seleon GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System:The MOBYBOX Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with cardiac, respiratory, or cardiorespiratory failure or imminent failure and meet at least one of the following: Murray score 63; 3.0 and/or severe hypoxemia with PaO2/FIO2 > 100 mm on 0.9 FIO2; uncompensated hypercapnia with pH <7.2 despite Pplateau > 30 cm H2O; significant air leak or bronchopleural fistula; need for intubation while on lung transplant list; immediate or risk of cardiac or respiratory collapse
- Patient or legal guardian or external consulting physician has provided written consent approved by the Ethics Committee
- Age between 18 and 80 years
You will not qualify if you...
- High pressure ventilation (FIO2 > 0.9 and Pplateau > 30 cm H2O) or high FIO2 requirements for more than 7 days
- Severe intracranial bleeding or inability to receive anticoagulation therapy
- Weight over 180 kilograms
- Severe irreversible brain injury such as hypoxic brain injury
- Inability to accept blood products
- Any condition or organ dysfunction limiting overall benefit from ECMO, including severe brain injury, liver or kidney failure, or untreatable metastatic cancer
- Immunosuppression with absolute neutrophil count < 400/mm3
- ECMO treatment within the last 48 hours
- For veno-venous ECMO: severe pulmonary hypertension (mPAP > 50 mm Hg) or severe heart failure (ejection fraction < 25%)
- For veno-arterial ECMO: severe aortic regurgitation or aortic dissection
- Patient is moribund or has severe or worsening damage in critical body systems
- Participation in another investigational drug or device study interfering with current study endpoints
- Any condition interfering with informed consent, study compliance, increasing risk, or confounding study results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
2
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany, 45147
Actively Recruiting
3
Universitätsklinikum Halle
Halle, Saxony-Anhalt, Germany, 06120
Actively Recruiting
4
Helios Klinikum Erfurt
Erfurt, Germany, 99089
Actively Recruiting
Research Team
Y
Yvonne Seibt
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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