Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-22 @ 9:36 AM
Study NCT ID:
NCT04183660
Status:
RECRUITING
Last Update Posted:
2025-05-31
First Post:
2019-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System:The MOBYBOX Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2019-11-27', 'studyFirstSubmitQcDate': '2019-11-28', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of device and procedure related serious adverse events', 'timeFrame': '24 hours', 'description': 'Acute safety defined as rates of device and procedure related serious adverse events up to 24 hours post-intervention.'}], 'secondaryOutcomes': [{'measure': 'Device performance success', 'timeFrame': 'every 4 hours while the patient receives ECMO using the MOBYBOX device', 'description': '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)'}, {'measure': 'Adverse Event rate', 'timeFrame': '24 hours', 'description': 'Acute safety defined as rates adverse events up to 24 hours post-intervention.'}, {'measure': 'Mortality rate', 'timeFrame': '30 days', 'description': 'All-cause mortality up to 30 days post-intervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Failure', 'Respiratory Failure', 'Cardio-Respiratory Failure', 'Imminent Cardiorespiratory or Respiratory Failure']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with cardiac, respiratory or cardiorespiratory failure or imminent failure and 1 of the 5 following sets of findings:\n\n 1. A Murray score ≥ 3.0 and/or severe hypoxemia with A PaO2/FIO2 \\> 100 mm on 0.9 FIO2;\n 2. Uncompensated hypercapnia with pH \\<7.2 despite a Pplateau \\> 30 cm H20;\n 3. Significant air leak/bronchopleural fistula;\n 4. Need for intubation in a patient on lung transplant list;\n 5. Immediate/risk of cardiac or respiratory collapse (pulmonary embolus, blocked airway, blocked blood flow, unresponsive to optimal care);\n* Written consent of the patient or the legal guardian or external consulting physician as designated and approved by the Ethics Committee.\n\nExclusion Criteria:\n\n* High pressure ventilation (FIO2 \\> 0.9 and Pplateau \\> 30 cm H2O) or high FIO2 requirements for more than 7 days;\n* Severe intracranial bleeding, which precludes the use of anticoagulation therapy or any other inability to be anticoagulated\n* Excessive weight (\\> 180 Kg)\n* Severe irreversible brain injury (e.g., hypoxic brain injury)\n* Inability to accept blood products;\n* 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;\n* Immunosuppression with an absolute neutrophil count \\< 400/mm3;\n* Patient has been treated with ECMO ≤ 48 hours.\n* For veno-veno ECMO in the setting of respiratory failure the following exclusion criteria apply:\n* Severe pulmonary hypertension (mPAP \\> 50 mm Hg)\n* Severe right or left sided heart failure (EF \\< 25%)\n* For veno-arterial ECMO in the setting of cardiac insufficiency:\n* Severe aortic regurgitation\n* Aortic dissection.\n* The patient is moribund, or the patient has severe or deteriorating damage in critical body systems.\n* 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.\n* 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."}, 'identificationModule': {'nctId': 'NCT04183660', 'briefTitle': 'A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System:The MOBYBOX Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hemovent GmbH'}, 'officialTitle': 'A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System for Cardiac and Respiratory Support: The MOBYBOX Trial', 'orgStudyIdInfo': {'id': 'HVT-MB1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MOBYBOX System', 'type': 'DEVICE', 'description': 'extracorporeal cardiopulmonary support'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Kühn, Professor', 'role': 'CONTACT', 'email': 'Kuehn.Christian@mh-hannover.de', 'phone': '+49 511 532-0'}, {'name': 'Heiko Schenk, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Olaf Wiesner, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '45147', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tienush Rassaf, Prof.', 'role': 'CONTACT', 'email': 'tienush.rassaf@uk-essen.de', 'phone': '+49 201 723-4801'}, {'name': 'Amir Abbas Mahabadi, Prof.', 'role': 'CONTACT', 'email': 'amir-abbas.mahabadi@uk-essen.de', 'phone': '+49 201 723-84822'}, {'name': 'Lars Michel, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Florian Schindhelm, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '06120', 'city': 'Halle', 'state': 'Saxony-Anhalt', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alexander Vogt, MD', 'role': 'CONTACT', 'email': 'alexander.vogt@uk-halle.de', 'phone': '+49 3455572601'}, {'name': 'Alexander Vogt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Adrian Kirsten, Doctor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Halle', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '99089', 'city': 'Erfurt', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Heinrich Groesdonk, Professor', 'role': 'CONTACT', 'email': 'heinrich.groesdonk@helios-gesundheit.de'}, {'name': 'Magdalena Römmer, Doctor', 'role': 'CONTACT', 'email': 'magdalena.roemmer@helios-gesundheit.de', 'phone': '+49 361 781-6075'}, {'name': 'Klaus Matzen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Udo Stelzer, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Helios Klinikum Erfurt', 'geoPoint': {'lat': 50.97734, 'lon': 11.03536}}], 'centralContacts': [{'name': 'Yvonne Seibt', 'role': 'CONTACT', 'email': 'yseibt@hemovent.com', 'phone': '+49 174 1773839'}], 'overallOfficials': [{'name': 'Tienush Rassaf, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uniklinikum Essen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hemovent GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'seleon GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}