RecruitingNot Applicable

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

Germany60 participantsStarted 2024-04-30

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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);

What they're measuring

Rates of device and procedure related serious adverse events

Timeframe: 24 hours

Trial details

NCT IDNCT04183660

SponsorHemovent GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-04

Contact for this trial

Yvonne Seibt

+49 174 1773839 yseibt@hemovent.com

View on ClinicalTrials.gov More Cardiac Failure trials