Study to Evaluate Performance of the Organ Recovery Systems LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant
NCT ID: NCT03484455
Last Updated: 2022-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
142 participants
INTERVENTIONAL
2019-04-03
2022-07-12
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
SINGLE
Study Groups
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Hypothermic Machine Perfusion
Hypothermic Machine Perfusion with Organ Recovery Systems LLT system
Hypothermic machine perfusion
Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution
Static Cold Storage
Standard of Care - Static Cold Storage
Static cold storage
Static cold storage (standard of care)
Interventions
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Hypothermic machine perfusion
Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution
Static cold storage
Static cold storage (standard of care)
Eligibility Criteria
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Inclusion Criteria
* Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation
* De novo liver transplant recipient
* Written informed consent required
Exclusion Criteria
* Subject is antibodies blood group (ABO) liver incompatible
* Subject has severe systemic infection
* Subject is Human Immunodeficiency Virus (HIV) positive
* Subject has acute/fulminant liver failure
* Subject is pregnant
18 Years
ALL
No
Sponsors
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Organ Recovery Systems, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stan Harris
Role: STUDY_DIRECTOR
Organ Recovery Systems
Matthew Copithorne
Role: STUDY_CHAIR
Organ Recovery Systems
Locations
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Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester Strong Memorial Hospital
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia Hospital
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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2017-US-01-ORS
Identifier Type: -
Identifier Source: org_study_id
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