Study Results
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View full resultsBasic Information
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COMPLETED
NA
267 participants
INTERVENTIONAL
2016-10-09
2021-02-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Normothermic Machine Perfusion (NMP)
Following the routine retrieval procedure of the liver, it will be placed on the OrganOx metra for Normothermic Machine Perfusion (NMP) for transport per the Investigational Plan and the Instructions For Use.
Normothermic Machine Perfusion (NMP)
Standard of Care (Ice)
Following the routine retrieval procedure of the liver, it will be placed in ice-cold perfusion solution within an ice box for transport as dictated by logistics and local policy.
Standard of Care (Ice)
Interventions
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Normothermic Machine Perfusion (NMP)
Standard of Care (Ice)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is registered as an active recipient on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation
* Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization
* Subject is able and willing to comply with all study requirements
Exclusion Criteria
* Subject has acute/fulminant liver failure
* Subject undergoing simultaneous transplantation of more than one organ
* Subject is pregnant or nursing
* Concurrent enrollment in another clinical trial. Subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) are allowed to participate.
18 Years
ALL
No
Sponsors
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North American Science Associates Ltd.
NETWORK
OrganOx Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Stuart Knechtle, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic - Phoenix
Phoenix, Arizona, United States
University of Southern California (USC)
Los Angeles, California, United States
University of California - Los Angeles (UCLA)
Los Angeles, California, United States
University of California-San Francisco (UCSF)
San Francisco, California, United States
University of Miami
Miami, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Ochsner
New Orleans, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University
St Louis, Missouri, United States
Duke University
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Wisconsin Madison
Madison, Wisconsin, United States
Countries
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References
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Kubal C, Mihaylov P, Holden J. Oncologic indications of liver transplantation and deceased donor liver allocation in the United States. Curr Opin Organ Transplant. 2021 Apr 1;26(2):168-175. doi: 10.1097/MOT.0000000000000866.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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WP01
Identifier Type: -
Identifier Source: org_study_id
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