Status:
COMPLETED
Study to Evaluate Performance of the Organ Recovery Systems LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant
Lead Sponsor:
Organ Recovery Systems, Inc.
Conditions:
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).
Detailed Description
Prospective, randomized, multi-center study to show safe and effective use of whole liver preservation via hypothermic machine perfusion (HMP) as compared to livers preserved by static cold storage.
Eligibility Criteria
Inclusion
- ≥18 years of age
- Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation
- De novo liver transplant recipient
- Written informed consent required
Exclusion
- Subject is a multi-organ transplant recipient
- 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
Key Trial Info
Start Date :
April 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2022
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT03484455
Start Date
April 3 2019
End Date
July 12 2022
Last Update
October 7 2022
Active Locations (9)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
2
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
3
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07101
4
Columbia University Medical Center
New York, New York, United States, 10032