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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHemovent GmbH

About this 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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • MOBYBOX System

Treatment groups

No treatment groups listed

Sponsors and collaborators

Hemovent GmbH

Lead sponsor

seleon GmbH

Collaborator