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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure; Cardiac Failure; Cardio-Respiratory Failure; Imminent Cardiorespiratory or Respiratory Failure
• Intervention / Treatment: Device: MOBYBOX System

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Yvonne Seibt; Phone Number: +49 174 1773839; Email: yseibt@hemovent.com

Study Locations

• Germany
  • Erfurt, Germany, 99089
    • Recruiting
    • HELIOS Klinikum Erfurt
    • Contact: Heinrich Groesdonk, Professor; Email: heinrich.groesdonk@helios-gesundheit.de
    • Contact: Magdalena Römmer, Doctor; Phone Number: +49 361 781-6075; Email: magdalena.roemmer@helios-gesundheit.de
    • Sub-Investigator: Klaus Matzen, MD
    • Sub-Investigator: Udo Stelzer, MD
  • NRW
    • Essen, NRW, Germany, 45147
      • Recruiting
      • Universitätsklinikum Essen
      • Sub-Investigator: Lars Michel, MD
      • Contact: Tienush Rassaf, Prof.; Phone Number: +49 201 723-4801; Email: tienush.rassaf@uk-essen.de
      • Contact: Amir Abbas Mahabadi, Prof.; Phone Number: +49 201 723-84822; Email: amir-abbas.mahabadi@uk-essen.de
      • Sub-Investigator: Florian Schindhelm, MD
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Recruiting
      • Medizinische Hochschule Hannover
      • Contact: Christian Kühn, Professor; Phone Number: +49 511 532-0; Email: Kuehn.Christian@mh-hannover.de
      • Sub-Investigator: Heiko Schenk, MD
      • Sub-Investigator: Olaf Wiesner, MD
  • Sachsen-Anhalt
    • Halle, Sachsen-Anhalt, Germany, 06120
      • Recruiting
      • Universitätsklinikum Halle
      • Principal Investigator: Alexander Vogt, MD
      • Contact: Alexander Vogt, MD; Phone Number: +49 3455572601; Email: alexander.vogt@uk-halle.de
      • Sub-Investigator: Adrian Kirsten, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consented patients with cardiorespiratory failure or ith severe respiratory failure who meet all of the inclusion and none of the exclusion criteria and in whom the investigator intends to treat the patient with cardiopulmonary support using the Hemovent MOBYBOX System.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of device and procedure related serious adverse events	Acute safety defined as rates of device and procedure related serious adverse events up to 24 hours post-intervention.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device performance success	Device performance success (defined as the ability to establish either veno-arterial ECMO to support cardiorespiratory function and tissue oxygenation or veno-venous ECMO to support respiratory function and tissue oxygenation)	every 4 hours while the patient receives ECMO using the MOBYBOX device
Adverse Event rate	Acute safety defined as rates adverse events up to 24 hours post-intervention.	24 hours
Mortality rate	All-cause mortality up to 30 days post-intervention	30 days

Collaborators and Investigators

• Sponsor: Hemovent GmbH
• Collaborators: seleon GmbH
• Investigators: Principal Investigator: Tienush Rassaf, Prof., Uniklinikum Essen

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: November 28, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Respiratory Tract Diseases; Respiration Disorders; Heart Failure; Respiratory Insufficiency
• Other Study ID Numbers: HVT-MB1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No