Checks the safety of the MOBYBOX heart and lung support device in patients
Studies the MOBYBOX device for heart or lung failure in adults aged 18 to 80.
Plain-language title generated from the registry record
Registry title: A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System:The MOBYBOX Trial
Key facts
- Where
- Erfurt, Essen, Halle, and Hanover, GermanySee the 4 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT04183660, who can take part
Where in Germany
- Helios Klinikum ErfurtErfurt, GermanyTaking people
- Universitätsklinikum EssenEssen, GermanyTaking people
- Universitätsklinikum HalleHalle, GermanyTaking people
- Medizinische Hochschule HannoverHanover, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hemovent GmbH
- Trial code
- NCT04183660
- Record updated
- 31 May 2025
- Original description
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.Read full original descriptionShow less
A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System for Cardiac and Respiratory Support: The MOBYBOX Trial
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.
Inclusion: Diagnosed with cardiac, respiratory or cardiorespiratory failure or imminent failure and 1 of the 5 following sets of findings:; A Murray score ≥ 3.0 and/or severe hypoxemia with A PaO2/FIO2 > 100 mm on 0.9 FIO2; Uncompensated hypercapnia with pH <7.2 despite a Pplateau > 30 cm H20; Significant air leak/bronchopleural fistula; Need for intubation in a patient on lung transplant list; Immediate/risk of cardiac or respiratory collapse (pulmonary embolus, blocked airway, blocked blood flow, unresponsive to optimal care); Written consent of the patient or the legal guardian or external consulting physician as designated and approved by the Ethics Committee.
Exclusion: Patient has been treated with ECMO ≤ 48 hours; Patient is participating in an investigational drug or device study trial that has not reached the primary endpoint or that interferes with the current study endpoints; Severe intracranial bleeding, which precludes the use of anticoagulation therapy or any other inability to be anticoagulated; Any condition or organ dysfunction that would limit the likelihood of overall benefit from ECMO, such as severe, irreversible brain injury, hepatic and/or renal failure, or untreatable metastatic cancer; For veno-veno ECMO in the setting of respiratory failure the following exclusion criteria apply:; Severe pulmonary hypertension (mPAP > 50 mm Hg); Severe right or left sided heart failure (EF < 25%); For veno-arterial ECMO in the setting of cardiac insufficiency:; Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results; Immunosuppression with an absolute neutrophil count < 400/mm3; High pressure ventilation (FIO2 > 0.9 and Pplateau > 30 cm H2O) or high FIO2 requirements for more than 7 days; Excessive weight (> 180 Kg); Severe irreversible brain injury (e.g., hypoxic brain injury); Inability to accept blood products; Severe aortic regurgitation; Aortic dissection; The patient is moribund, or the patient has severe or deteriorating damage in critical body systems.