Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-07 @ 1:21 PM
Study NCT ID:
NCT05074160
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-10
First Post:
2021-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OCS Liver Perfusion (OLP) Post-Approval Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2021-09-29', 'studyFirstSubmitQcDate': '2021-09-29', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety Endpoint', 'timeFrame': '6 months post-Liver transplant', 'description': '6-months liver graft survival post-Liver transplant'}, {'measure': 'Long Term Patient Survival', 'timeFrame': '2 years post-transplant', 'description': 'K-M Patient survival at 1- and 2-years post-transplant'}, {'measure': 'Long Term Graft Survival', 'timeFrame': '2 years post-transplant', 'description': 'K-M Graft survival at 6 months, 1- and 2-years post-transplant'}], 'primaryOutcomes': [{'measure': 'Patient Survival', 'timeFrame': '1 year post-Liver transplant', 'description': '1-year patient survival with the originally transplanted liver (patient and graft survival) post-Liver transplant.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Liver Transplant']}, 'descriptionModule': {'briefSummary': 'The objective of the OLP Registry is to collect more data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on OCS Liver System according to the approved indication and the OCS device performance in the real-world setting.', 'detailedDescription': 'OLP Registry is a multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Potential participants in the OLP Registry will be all adult primary liver transplant candidates on the waiting list for liver transplant at a U.S. liver transplant center and who meet the eligibility criteria at the participating Registry centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult primary liver transplant recipients of DBD or DCD donor Livers perfused on OCS Liver System\n\nDonor Exclusion Criteria:\n\n* Donor livers with accessory arterial blood supply requiring back table anastomosis, major traumatic injury, or hematoma; or\n* Split donor liver; or\n* DCD donor liver with \\>30 minutes of warm ischemic time (defined as from withdrawal of life support until donor liver cold flush); or\n* DCD donors age \\>55 years; or\n* DCD donor liver with macrosteatosis of \\>15%\n* Living donors\n* Donors with positive serology for HIV, Hep B and C\n* Donors with macrosteatosis of ≥40%\n\nRecipient Exclusion Criteria:\n\n* Fulminant liver failure; or\n* Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or\n* Chronic renal dialysis at time of transplant; or\n* Dependency on more than 1 inotropic agent to maintain hemodynamics; or\n* Ventilator dependent at time of transplant.'}, 'identificationModule': {'nctId': 'NCT05074160', 'briefTitle': 'OCS Liver Perfusion (OLP) Post-Approval Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'TransMedics'}, 'officialTitle': 'OCS Liver Perfusion (OLP) Post-Approval Registry', 'orgStudyIdInfo': {'id': 'OCSLIVER-01-PAS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OLP Registry primary analysis population', 'description': 'Adult primary liver transplant recipients who are transplanted with an OCS perfused DBD or DCD donor liver according to the approved indication and matching eligibility criteria', 'interventionNames': ['Device: OCS Liver']}], 'interventions': [{'name': 'OCS Liver', 'type': 'DEVICE', 'description': 'Multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.', 'armGroupLabels': ['OLP Registry primary analysis population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TransMedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}