Study Results
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View full resultsBasic Information
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TERMINATED
NA
9 participants
INTERVENTIONAL
2020-07-24
2024-12-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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OCS Preserved Livers
This is a single-arm trial of OCS preserved livers used for transplantation.
OCS Liver System
The OCS Liver System will be used to preserve, optimize and assess livers from DCD donors.
Interventions
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OCS Liver System
The OCS Liver System will be used to preserve, optimize and assess livers from DCD donors.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Obtained informed consent
Exclusion Criteria
* Prior solid organ or bone marrow transplant
* Ventilator dependent on day of transplant/donor organ offer
18 Years
ALL
No
Sponsors
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TransMedics
INDUSTRY
Responsible Party
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Principal Investigators
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Ahmed Elbetanony, MD
Role: STUDY_DIRECTOR
TransMedics
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mount Sinai Hospital
New York, New York, United States
University of Texas San Antonio
San Antonio, Texas, 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 and Statistical Analysis Plan
Other Identifiers
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OCS-LVR-092019
Identifier Type: -
Identifier Source: org_study_id
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