NCT04183660 A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System:The MOBYBOX Trial
| NCT ID | NCT04183660 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hemovent GmbH |
| Condition | Cardiac Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-04-30 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-04-30 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Diagnosed with cardiac, respiratory or cardiorespiratory failure or imminent failure and 1 of the 5 following sets of findings: 1. A Murray score ≥ 3.0 and/or severe hypoxemia with A PaO2/FIO2 \> 100 mm on 0.9 FIO2; 2. Uncompensated hypercapnia with pH \<7.2 despite a Pplateau \> 30 cm H20; 3. Significant air leak/bronchopleural fistula; 4. Need for intubation in a patient on lung transplant list; 5. 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 Criteria: * High pressure ventilation (FIO2 \> 0.9 and Pplateau \> 30 cm H2O) or high FIO2 requirements for more than 7 days; * Severe intracranial bleeding, which precludes the use of anticoagulation therapy or any other inability to be anticoagulated * Excessive weight (\> 180 Kg) * Severe irreversible brain injury (e.g., hypoxic brain injury) * Inability to accept blood products; * 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; * Immunosuppression with an absolute neutrophil count \< 400/mm3; * Patient has been treated with ECMO ≤ 48 hours. * 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: * Severe aortic regurgitation * Aortic dissection. * The patient is moribund, or the patient has severe or deteriorating damage in critical body systems. * 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. * 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.
Contact & Investigator
Tienush Rassaf, Prof.
PRINCIPAL INVESTIGATOR
Uniklinikum Essen
Frequently Asked Questions
Who can join the NCT04183660 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Cardiac Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04183660 currently recruiting?
Yes, NCT04183660 is actively recruiting participants. Contact the research team at yseibt@hemovent.com for enrollment information.
Where is the NCT04183660 trial being conducted?
This trial is being conducted at Hanover, Germany, Essen, Germany, Halle, Germany, Erfurt, Germany.
Who is sponsoring the NCT04183660 clinical trial?
NCT04183660 is sponsored by Hemovent GmbH. The principal investigator is Tienush Rassaf, Prof. at Uniklinikum Essen. The trial plans to enroll 60 participants.