Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-05 @ 6:22 PM
Study NCT ID:
NCT05940857
Status:
RECRUITING
Last Update Posted:
2024-08-16
First Post:
2023-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
US National OCS Liver Perfusion (OLP) Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2031-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2023-06-29', 'studyFirstSubmitQcDate': '2023-07-10', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '5 years post-transplant', 'description': "Recipients' patient and graft survival rates will be the primary clinical outcomes measures for all OCS Liver transplanted recipients compared to recipients receiving liver transplants using non-OCS preservation methods (cold static storage or other perfusion devices or a combination of both). This data will be obtained directly from UNOS/OPTN database."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Liver Transplant']}, 'descriptionModule': {'briefSummary': 'This Registry is a sponsor-initiated, multi-center, observational, post-approval registry with an independent academic oversight.\n\nTransMedics has contracted with United Network for Organ Sharing (UNOS) the Federal manager of the U.S. national transplant outcomes registry to obtain data that is routinely collected by the Organ Procurement and Transplantation Network (OPTN) on all transplanted organs in the U.S. for both the OCS liver transplanted patients as well as patients transplanted using other preservation modalities. Additional data will be collected by participating centers using OCS Liver perfusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All liver transplant recipients who are transplanted with an OCS-perfused donor liver will be enrolled in the Registry. Patients' clinical outcomes will be followed until the later of 5 years post-transplant, loss to follow-up or death.", 'healthyVolunteers': False, 'eligibilityCriteria': 'All liver transplant recipients.'}, 'identificationModule': {'nctId': 'NCT05940857', 'acronym': 'National OLP', 'briefTitle': 'US National OCS Liver Perfusion (OLP) Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'TransMedics'}, 'officialTitle': 'US National OCS Liver Perfusion (OLP) Registry', 'orgStudyIdInfo': {'id': 'OCS-LIVER-OLP-II'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OCS Liver Transplant Recipients', 'description': 'The US National OLP Registry will enroll all liver transplant recipients who are transplanted with an OCS-perfused donor liver in the Registry.', 'interventionNames': ['Device: OCS Liver']}, {'label': 'Non-OCS Liver Transplant Recipients', 'description': 'Patients transplanted using other preservation modalities for clinical outcomes.'}], 'interventions': [{'name': 'OCS Liver', 'type': 'DEVICE', 'description': 'The TransMedics® Organ Care System (OCS) Liver is an FDA approved portable extracorporeal liver perfusion and monitoring system.', 'armGroupLabels': ['OCS Liver Transplant Recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leigh McManus', 'role': 'CONTACT'}, {'name': 'Robert Cannon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dakota Hohenwalter', 'role': 'CONTACT'}, {'name': 'Amit K. Mathur, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic Hospital Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Denya Arellano', 'role': 'CONTACT'}, {'name': 'Gabriel Schnickel, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joanne Kwan', 'role': 'CONTACT'}, {'name': 'Garrett Roll, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Toukmehji', 'role': 'CONTACT'}, {'name': 'Shennen Mao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic Hospital Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeryl Huckaby', 'role': 'CONTACT'}, {'name': 'Denise Jennifer Lo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Deepa Valvi', 'role': 'CONTACT'}, {'name': 'Malay B Shah', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kentucky Medical Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Madelyn Subocz', 'role': 'CONTACT'}, {'name': 'David D. Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kirsten Peterson', 'role': 'CONTACT'}, {'name': 'Mohamed E. Akoad, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lahey Clinic Medical Center', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicholas Demchuk', 'role': 'CONTACT'}, {'name': 'Seth Waits, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Callaghan', 'role': 'CONTACT'}, {'name': 'Iman Francis', 'role': 'CONTACT'}, {'name': 'Ahmed Nassar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Candy Peterman', 'role': 'CONTACT'}, {'name': 'Julie K. Heimbach, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic Hospital Minnesota', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63103', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Craig Dedert', 'role': 'CONTACT'}, {'name': 'Henry Randall, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SSM Health Saint Louis University Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michelle Leahy', 'role': 'CONTACT'}, {'name': 'Shaheed Merani, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Nuccitelli', 'role': 'CONTACT'}, {'name': 'Tomoaki Kato, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NY Presbyterian Hospital/Columbia Univ. Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katheryn Peterson', 'role': 'CONTACT'}, {'name': 'Dionisios Vrochides, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carolinas Medical Center/Atrium Health', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jerry Turner', 'role': 'CONTACT'}, {'name': 'Debra Sudan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Willa Meyer', 'role': 'CONTACT'}, {'name': 'Ashesh Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Morgan Marsh', 'role': 'CONTACT'}, {'name': 'David Wojciechowski, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Deborah Pokrass', 'role': 'CONTACT'}, {'name': 'Mark Hobeika, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Houston Methodist', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jillian Woodworth', 'role': 'CONTACT'}, {'name': 'Tarunjeet S Klair, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital, University of Texas Health Science Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chinedu Nwaduru, MD', 'role': 'CONTACT'}, {'name': 'Motaz Selim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Utah Medical Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Kelly Jork', 'role': 'CONTACT', 'email': 'kjork@transmedics.com', 'phone': '978-494-3918'}, {'name': 'Kausar Qidwai', 'role': 'CONTACT', 'email': 'kqidwai@transmedics.com'}], 'overallOfficials': [{'name': 'Ahmed Elbetanony, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'TransMedics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TransMedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}