Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-28 @ 7:36 AM
Study NCT ID:
NCT00879268
Status:
COMPLETED
Last Update Posted:
2009-04-09
First Post:
2009-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-07', 'studyFirstSubmitDate': '2009-04-07', 'studyFirstSubmitQcDate': '2009-04-07', 'lastUpdatePostDateStruct': {'date': '2009-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Liver Transplantation', 'Organ Preservation', 'Liver Preservation', 'Machine Perfusion', 'Vasosol', 'Machine Preservation'], 'conditions': ['Liver Transplantation', 'Organ Preservation']}, 'descriptionModule': {'briefSummary': 'This is a pilot trial of centrifugal machine preservation of donor livers for transplantation using a novel preservation solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary/ Solitary Liver Transplant\n* Lab MELD\\<35\n* Donor age \\<65\n\nExclusion Criteria:\n\n* Donor Liver \\> 30% Macrosteatosis\n* DCD donor liver\n* Multi-organ Recipient\n* Recipient in ICU\n* Retransplant'}, 'identificationModule': {'nctId': 'NCT00879268', 'briefTitle': 'Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System', 'organization': {'class': 'INDIV', 'fullName': 'Polyak, Maximilian'}, 'officialTitle': 'Phase 1 Study of Liver Machine Preservation With Vasosol Solution', 'orgStudyIdInfo': {'id': 'G030132'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System', 'type': 'DEVICE', 'otherNames': ['Vasosol Solution', 'Medtronic Portable Bypass System'], 'description': 'Utilization of Vasosol with Medtronic System for Machine Preservation of the Liver for Liver Transplantation'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'James V. Guarrera, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Polyak, Maximilian', 'class': 'INDIV'}, 'collaborators': [{'name': 'Health Resources and Services Administration (HRSA)', 'class': 'FED'}], 'responsibleParty': {'oldNameTitle': 'Dr. James V. Guarrera', 'oldOrganization': 'Columbia University Medical Center'}}}}