Global Utilization And Registry Database for Improved preservAtion of doNor Livers

Paragonix Technologies

Status: Invitation-only

Conditions: Liver Transplant Disorder; Liver Transplant Rejection; Liver Dysfunction; Liver Diseases

Treatments: Device: LIVERguard

Study type: Observational

Funder types: Industry

Identifiers

NCT05082077

PGX-005

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,000 participants in 2 patient groups

LIVERguard patient

Description:

Patients whose donor liver was transported with the LiverGuard device.

Treatment:

Device: LIVERguard

Standard Transport Patients

Description:

Patients whose donor liver was transported with a method other than the LiverGuard