Global Utilization And Registry Database for Improved preservAtion of doNor Livers

NCT05082077 · tracked via the Priya Life Science USA tracker

Sponsor

Paragonix Technologies

Phase

Observational

Started

2022-03-15

Last updated

2026-09-17

Condition(s) studied

Liver DiseasesLiver DysfunctionLiver Transplant DisorderLiver Transplant Rejection

Investigational drug(s) / intervention(s)

LIVERguard

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.

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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: * Donor and donor liver matched to the recipient based upon institutional medical practice * Registered male or female liver transplant candidates Exclusion Criteria: * Donor and donor liver that do not meet institutional clinical requirements for transplantation * Living donors

Primary outcome measure(s)

Graft Failure — Post-transplant through 1 year post
The percentage of subjects in each cohort who develop graft failure post-transplant
Early allograft dysfunction — 7 days post transplant
The percentage of subjects in each cohort who early allograft failure post-transplant
Rejection — Post-transplant through 1 year post
The percentage of subjects in each cohort who experience rejection post-transplant
Primary Non-function — Post transplant to 7 days post-transplant
The percentage of subjects in each cohort who experience primary non-function post-transplant
Survival — Transplant through 1 year post-transplant
The percentage of subjects in each cohort who survive through 1 year post-transplant
Length of Stay — 1 year
How many days the patient stays in the hospital post-transplant
Length of ICU stay — 1 year
How many days the patient stayed in the ICU post-transplant

Trial sites (15)

Facility	City	Region
University of Alabama at Birmingham	Birmingham	Alabama
University of California San Diego	San Diego	California
Stanford University	Stanford	California
University of Florida	Gainesville	Florida
Mayo Clinic Jacksonville	Jacksonville	Florida
Tampa General Hospital	Tampa	Florida
Piedmont Healthcare	Atlanta	Georgia
University of Maryland, Baltimore	Baltimore	Maryland
Lahey Clinic	Burlington	Massachusetts
University of Nebraska	Omaha	Nebraska
Duke University	Durham	North Carolina
University of Cincinnati	Cincinnati	Ohio
University of Texas Health Science Center at San Antonio	San Antonio	Texas
Intermountain Health Center	Salt Lake City	Utah
University of Washington	Seattle	Washington

More Paragonix Technologies trials in the USA

Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs Enrolling by invitation

Global Utilization And Registry Database for Improved heArt preservatioN Enrolling by invitation

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05082077 on ClinicalTrials.gov ↗ ← All trials in the USA