Actively Recruiting
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
60
Participants Needed
4
Research Sites
34 weeks
Total Duration
On this page
Sponsors
H
Hemovent GmbH
Lead Sponsor
S
seleon GmbH
Collaborating Sponsor
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 device's 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of device use as needed for cardiac and respiratory support
Participants receive extracorporeal cardiopulmonary support using the MOBYBOX System device.
Continuous monitoring every 4 hours while receiving ECMO support
Duration - Up to 30 days post device use
Participants are monitored for safety and device performance after device use ends.
Follow-up visits as needed within 30 days
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
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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