NCT05082077

Global Utilization And Registry Database for Improved preservAtion of doNor Livers

Global Utilization and Registry Database for Improved Preservation of Donor Livers

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Paragonix Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Liver Diseases
• Liver Dysfunction
• Liver Transplant Disorder
• Liver Transplant Rejection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-15
• Primary completion: 2027-08-01
• Completion: 2028-01-01
• First posted: 2021-10-18
• Last updated: 2025-05-15

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study