Evaluating the safety and performance of the MOBYBOX System for heart and lung support

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the safety and effectiveness of the MOBYBOX Extracorporeal Cardiopulmonary Support System in patients experiencing cardiac, respiratory, or cardiorespiratory failure. The study will evaluate the device's performance in both veno-arterial and veno-venous configurations, depending on the patient's specific condition. Patients will be monitored for safety outcomes and device performance metrics, providing valuable data on its use in critical care settings.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Tienush Rassaf, Prof. — Uniklinikum Essen
• Study coordinator: Yvonne Seibt
• Email: yseibt@hemovent.com
• Phone: +49 174 1773839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Platelet population changes during ECMO circulatory support

  This will test whether the proportions of different platelet types change during ECMO in adults with cardiac or respiratory failure.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07334457

• Effect of phosphocreatine on patients treated by medical emergency teams

  This study tests if giving phosphocreatine to hospitalized patients with serious conditions can help them recover faster and shorten their hospital stays compared to those who receive a placebo.

  Recruiting Phase 3 Università Vita-Salute San Raffaele · Milan · NCT06503016

• Observing recovery from weakness after severe respiratory and cardiac failure

  This study looks at how people who had severe breathing and heart problems recover from weakness after being in intensive care and on a special life-support machine, to see what helps or hinders their recovery.

  Recruiting Barts & The London NHS Trust · London · NCT03753412

• HFNC During Bronchoscopy for Respiratory Failure

  This study tests whether using high-flow nasal oxygen during fiber-optic bronchoscopy is safe and helpful for patients with respiratory failure.

  Recruiting Mansoura University · Al Mansurah, Dakahlia Governorate · NCT07880964

• Respiratory progression in adults with Duchenne muscular dystrophy: a long-term observational study

  This study tests how respiratory function changes over three years in adults with genetically confirmed Duchenne muscular dystrophy.

  Recruiting at 13 sites Istituto Giannina Gaslini · Bologna and 12 other locations · NCT07879989

• Epidural spinal cord stimulation to help breathing after cervical spinal cord injury

  This trial tests whether adding epidural spinal cord stimulation to standard care can improve breathing in adults with cervical spinal cord injury and respiratory failure.

  Recruiting at 2 sites Zhongda Hospital · Nanjing, Jiangsu and 1 other locations · NCT07722130

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.