Global Utilization And Registry Database for Improved preservAtion of doNor Livers

Last updated: May 12, 2025
Sponsor: Paragonix Technologies
Overall Status: Active - Enrolling

Phase

N/A

Condition

Primary Biliary Cholangitis

Liver Transplantation

Liver Failure

Treatment

LIVERguard

Clinical Study ID

NCT05082077
PGX-005
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Donor and donor liver matched to the recipient based upon institutional medicalpractice

  • Registered male or female primary liver transplant candidates

Exclusion

Exclusion Criteria:

  • Donor and donor liver that do not meet institutional clinical requirements fortransplantation

  • Living donors

  • Pediatric recipients (under 18)

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: LIVERguard
Phase:
Study Start date:
March 15, 2022
Estimated Completion Date:
January 31, 2028

Study 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.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Stanford University

    Stanford, California 94305
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32608
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • University of Nebraska

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98109
    United States

    Site Not Available

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