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Global Utilization And Registry Database for Improved preservAtion of doNor Livers

NCT05082077 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-05-15

No results posted yet for this 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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Paragonix Technologies

    lead INDUSTRY

Principal Investigators

  • Jason Vanatta, MD · Methodist Le Bonheur Healthcare

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-15
Primary Completion
2027-08-31
Completion
2028-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05082077 on ClinicalTrials.gov