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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05082077
Other study ID # PGX-005
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 15, 2022
Est. completion date January 2026

Study information

Verified date March 2024
Source Paragonix Technologies
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

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


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1000
Est. completion date January 2026
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Donor and donor liver matched to the recipient based upon institutional medical practice - Registered male or female primary liver transplant candidates Exclusion Criteria: - Donor and donor liver that do not meet institutional clinical requirements for transplantation - Living donors - Pediatric recipients (under 18)

Study Design


Intervention

Device:
LIVERguard
The LIVERguard is an FDA cleared and is a CE-marked medical device intended to be used for the static hypothermic preservation of livers during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the liver. The intended organ storage time for the LIVERguard is up to 16 hours.

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama
United States Duke University Durham North Carolina
United States University of Florida Gainesville Florida
United States University of Nebraska Omaha Nebraska
United States University of Washington Seattle Washington
United States Stanford University Stanford California
United States Tampa General Hospital Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Paragonix Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Graft Failure The percentage of subjects in each cohort who develop graft failure post-transplant Post-transplant through 1 year post
Primary Early allograft dysfunction The percentage of subjects in each cohort who early allograft failure post-transplant 7 days post transplant
Primary Rejection The percentage of subjects in each cohort who experience rejection post-transplant Post-transplant through 1 year post
Primary Primary Non-function The percentage of subjects in each cohort who experience primary non-function post-transplant Post transplant to 7 days post-transplant
Primary Survival The percentage of subjects in each cohort who survive through 1 year post-transplant Transplant through 1 year post-transplant
Primary Length of Stay How many days the patient stays in the hospital post-transplant 1 year
Primary Length of ICU stay How many days the patient stayed in the ICU post-transplant 1 year
Secondary Hospitalizations Amount of times patient is rehospitalized after discharge post-transplant post-transplant through 1 year
Secondary Biliary complications Percentage of patients that experience biliary strictures in each cohort as determined by lab work post-transplant through 1 year post-transplant
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