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Global Utilization And Registry Database for Improved preservAtion of doNor Livers

Liver Diseases Clinical Trial

Official title:
Global Utilization and Registry Database for Improved Preservation of Donor Livers

Clinical Trial Summary

The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor liver that were preserved and transported within the LIVERguard system, as well as retrospective standard of care patients

Clinical Trial Description

GUARDIAN-Liver is a post-market, observational registry of adult and pediatric liver transplant recipient patients whose donor liver was preserved and transported within the LIVERguard. The data is being collected retrospectively from medical records of patients already transplanted before the initiation of the registry and any new patients who meet the eligibility criteria. About 1000 male and female subjects meeting the study inclusion and exclusion criteria will be enrolled into the study at about 20 clinical sites. Candidates that fit the eligibility criteria and have had their donor liver transported with a Paragonix product or a standard of care method can be enrolled. The baseline characteristics and outcomes of the two groups will be compared. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05082077
Study type Observational [Patient Registry]
Source Paragonix Technologies
Contact
Status Enrolling by invitation
Phase
Start date March 15, 2022
Completion date January 2026
View Details
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