Global Utilization And Registry Database for Improved preservAtion of doNor Livers

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Paragonix Technologies
Study ID
NCT05082077
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • LIVERguard — DEVICE
    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 Details

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

Key Dates

First listed
Oct 18, 2021
Start date
Mar 15, 2022
Status verified
Sep 2026
Primary completion
Aug 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: LIVERguard patient
    Patients whose donor liver was transported with the LiverGuard device.
  • Arm: Standard Transport Patients
    Patients whose donor liver was transported with a method other than the LiverGuard

Primary Outcome Measure

Graft Failure [ Time Frame: Post-transplant through 1 year post ]

Locations (15)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
University of California San DiegoSan DiegoCalifornia92093-0990-
Stanford UniversityStanfordCalifornia94305-
University of FloridaGainesvilleFlorida32608-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
Tampa General HospitalTampaFlorida33606-
Piedmont HealthcareAtlantaGeorgia30309-
University of Maryland, BaltimoreBaltimoreMaryland21201-
Lahey ClinicBurlingtonMassachusetts01805-
University of NebraskaOmahaNebraska68198-
Duke UniversityDurhamNorth Carolina27710-
University of CincinnatiCincinnatiOhio45221-
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-3901-
Intermountain Health CenterSalt Lake CityUtah84111-
University of WashingtonSeattleWashington98109-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of California San Diego· San Diego, CAStanford University· Stanford, CAUniversity of Florida· Gainesville, FLMayo Clinic Jacksonville· Jacksonville, FLTampa General Hospital· Tampa, FL

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