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Clinical Trials in Germany / NCT04183660
Recruiting Observational

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

NCT04183660 · tracked via the Priya Life Science Germany tracker
Sponsor
Hemovent GmbH
Phase
Observational
Started
2024-04-30
Last updated
2025-05-31

Condition(s) studied

Cardiac FailureRespiratory FailureCardio-Respiratory FailureImminent Cardiorespiratory or Respiratory Failure

Investigational drug(s) / intervention(s)

MOBYBOX System

MOBYBOX System: extracorporeal cardiopulmonary support

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Medizinische Hochschule Hannover Hanover Lower Saxony Recruiting
Universitätsklinikum Essen Essen North Rhine-Westphalia Recruiting
Universitätsklinikum Halle Halle Saxony-Anhalt Recruiting
Helios Klinikum Erfurt Erfurt Germany Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04183660 on ClinicalTrials.gov ↗ ← All trials in Germany