Liver DiseasesNCT05082077
Global Utilization And Registry Database for Improved preservAtion of doNor Livers
An observational study of Liver Diseases and Liver Dysfunction, run by Paragonix Technologies at 15 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Diseases, Liver Dysfunction, Liver Transplant Disorder
- What is being tested?
- LIVERguard
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 15 sitesUnited States
- Study dates
- 15 Mar 2022to Jan 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have received a liver transplant at centers that use the LIVERguard device
Who may be able to join
- Donor and donor liver matched to the recipient based upon institutional medical practice
- Registered male or female liver transplant candidates
Who cannot join
- Donor and donor liver that do not meet institutional clinical requirements for transplantation
- Living donors
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites
Piedmont Healthcare
Atlanta, Georgia, 30309
University of Maryland, Baltimore
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Lahey Clinic
Burlington, Massachusetts, 01805
University of Cincinnati
Cincinnati, Ohio, 45221
Duke University
Durham, North Carolina, 27710
University of Florida
Gainesville, Florida, 32608
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
University of Nebraska
Omaha, Nebraska, 68198
Intermountain Health Center
Salt Lake City, Utah, 84111
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3901
University of California San Diego
San Diego, California, 92093-0990
University of Washington
Seattle, Washington, 98109
Stanford University
Stanford, California, 94305
Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: Global Utilization and Registry Database for Improved Preservation of Donor Livers
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
Read the 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 2,000 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.
- Being tested
- LIVERguard
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIVERguardDevice
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 group | Role | What they receive |
|---|---|---|
| LIVERguard patient | Patients whose donor liver was transported with the LiverGuard device. Receives: Device: LIVERguard | |
| Standard Transport Patients | Patients whose donor liver was transported with a method other than the LiverGuard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Failure
The percentage of subjects in each cohort who develop graft failure post-transplant
Measured: Post-transplant through 1 year post
Early allograft dysfunction
The percentage of subjects in each cohort who early allograft failure post-transplant
Measured: 7 days post transplant
Rejection
The percentage of subjects in each cohort who experience rejection post-transplant
Measured: Post-transplant through 1 year post
Primary Non-function
The percentage of subjects in each cohort who experience primary non-function post-transplant
Measured: Post transplant to 7 days post-transplant
Survival
The percentage of subjects in each cohort who survive through 1 year post-transplant
Measured: Transplant through 1 year post-transplant
Length of Stay
How many days the patient stays in the hospital post-transplant
Measured: 1 year
Length of ICU stay
How many days the patient stayed in the ICU post-transplant
Measured: 1 year
Secondary outcomes (2)
Hospitalizations
Amount of times patient is rehospitalized after discharge post-transplant
Measured: post-transplant through 1 year
Biliary complications
Percentage of patients that experience biliary strictures in each cohort as determined by lab work
Measured: post-transplant through 1 year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start15 Mar 2022
- Primary completionAug 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Paragonix Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Vanatta, MD, Principal investigator, Methodist Le Bonheur Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082077
- Sponsor's protocol ID
- PGX-005
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2021
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Utilization and Registry Database for Improved Preservation of Donor Livers
- ClinicalTrials.gov ID
- NCT05082077
- Acronym / sponsor ID
- PGX-005
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Paragonix TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 2,000 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIVERguard patient | – | Device: LIVERguardPatients whose donor liver was transported with the LiverGuard device. |
| Standard Transport Patients | – | –Patients whose donor liver was transported with a method other than the LiverGuard |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have received a liver transplant at centers that use the LIVERguard device
Key inclusion criteria (2 listed)
- Donor and donor liver matched to the recipient based upon institutional medical practice
- Registered male or female liver transplant candidates
Key exclusion criteria (2 listed)
- Donor and donor liver that do not meet institutional clinical requirements for transplantation
- Living donors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIVERguardThe 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. | Device | LIVERguard patient |
Primary outcome
Graft Failure
Time frame: Post-transplant through 1 year post
The percentage of subjects in each cohort who develop graft failure post-transplant
Early allograft dysfunction
Time frame: 7 days post transplant
The percentage of subjects in each cohort who early allograft failure post-transplant
Rejection
Time frame: Post-transplant through 1 year post
The percentage of subjects in each cohort who experience rejection post-transplant
Primary Non-function
Time frame: Post transplant to 7 days post-transplant
The percentage of subjects in each cohort who experience primary non-function post-transplant
Survival
Time frame: Transplant through 1 year post-transplant
The percentage of subjects in each cohort who survive through 1 year post-transplant
Length of Stay
Time frame: 1 year
How many days the patient stays in the hospital post-transplant
Length of ICU stay
Time frame: 1 year
How many days the patient stayed in the ICU post-transplant
2 secondary outcomes
Hospitalizations
Time frame: post-transplant through 1 year
Biliary complications
Time frame: post-transplant through 1 year post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Vanatta, MD principal investigator
Methodist Le Bonheur Healthcare
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Liver Dysfunction, run by Paragonix Technologies at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft Failure (time frame: Post-transplant through 1 year post). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.