Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-29 @ 10:23 AM
Study NCT ID:
NCT05574361
Status:
RECRUITING
Last Update Posted:
2024-09-03
First Post:
2022-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-29', 'studyFirstSubmitDate': '2022-10-06', 'studyFirstSubmitQcDate': '2022-10-06', 'lastUpdatePostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early Allograft Dysfunction (EAD)', 'timeFrame': '7 days', 'description': 'EAD defined as total bilirubin ≥ 10 mg/dL or International Normalized Ratio (INR) ≥ 1.6 or Aspartate Aminotransferase (AST) \\>2000IU/L or Alanine Aminotransferase (ALT) \\> 2000 IU/L'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial', 'detailedDescription': 'To provide continued access for the LLT System with Vasosol® for the preservation of whole explanted livers, thereby providing additional safety data in support of the PILOT pivotal efficacy and safety trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* ≥18 years of age.\n* Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation.\n* De novo liver transplant recipient.\n* Written informed consent required.\n\nExclusion Criteria:\n\n* Subject is a multi-organ transplant recipient.\n* Subject is antibodies blood group (ABO) liver incompatible.\n* Subject has severe systemic infection.\n* Subject is Human Immunodeficiency Virus (HIV) positive.\n* Subject has acute/fulminant liver failure.\n* Subject is pregnant.'}, 'identificationModule': {'nctId': 'NCT05574361', 'acronym': 'PILOT™_CA', 'briefTitle': 'Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organ Recovery Systems, Inc.'}, 'officialTitle': 'A Prospective Multi-Center Continued Access Protocol for the Use of the LifePort® Liver Transporter (LLT) System With Vasosol® in Orthotopic Liver Transplants (PILOT™_CA: Perfusion to Improve Liver Outcomes in Transplantation_ Continued Access Arm)', 'orgStudyIdInfo': {'id': '2020-US-02-ORS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypothermic Machine Perfusion', 'description': 'Hypothermic Machine Perfusion with Organ Recovery Systems LifePort Liver Transporter system', 'interventionNames': ['Device: Hypothermic Machine Perfusion']}], 'interventions': [{'name': 'Hypothermic Machine Perfusion', 'type': 'DEVICE', 'description': 'Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution', 'armGroupLabels': ['Hypothermic Machine Perfusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel Borja-Cacho, MD', 'role': 'CONTACT'}], 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Fung, MD', 'role': 'CONTACT'}], 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '07101', 'city': 'Newark', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James V. Guarrera, MD', 'role': 'CONTACT'}], 'facility': 'Rutgers New Jersey Medical School', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shimul Shah, MD', 'role': 'CONTACT'}], 'facility': 'University of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Stan Harris', 'role': 'CONTACT', 'email': 'sharris@organ-recovery.com', 'phone': '847-824-2600'}, {'name': 'Carrie Lindower', 'role': 'CONTACT', 'email': 'clindower@organ-recovery.com', 'phone': '847-824-2600'}], 'overallOfficials': [{'name': 'Stan Harris', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Organ Recovery Systems'}, {'name': 'Matthew Copithorne', 'role': 'STUDY_CHAIR', 'affiliation': 'Organ Recovery Systems'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organ Recovery Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}