Global Utilization And Registry Database for Improved preservAtion of doNor Pancreata (GUARDIAN-PANCREAS)

March 17, 2026 updated by: Paragonix Technologies
The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving pancreas transplants using donor pancreata transported via the PancreasPak system. These results will be compared to standard of care outcomes, as well as other preservation methods.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

GUARDIAN-PANCREAS is a post-market, observational registry of adult transplant recipient patients whose donor pancreas was preserved and transported within the PancreasPak. 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 subjects meeting the study inclusion and exclusion criteria will be enrolled into the study at about 15 clinical sites.

Candidates that fit the eligibility criteria and have had their donor pancreas 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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have received a pancreas transplant at centers that use the PancreasPak device.

Description

Inclusion Criteria:

• Adult or pediatric recipients of pancreas alone, simultaneous pancreas-kidney, or pancreas after kidney transplant

Exclusion Criteria:

  • Donor pancreata that do not meet institutional clinical requirements for transplantation
  • Simultaneous pancreas-kidney transplant recipients who received donor organs from multiple donors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PancreasPak patient
Patients whose donor pancreas was transported with the PancreasPak device.
Device: PancreasPak
The PancreasPak Donor Preservation System is a FDA cleared and CE-marked medical device intended to be used for the static hypothermic preservation of donor pancreata during transportation and eventual transplantation using cold preservation solutions indicated for use in donor pancreata transplantation. The intended organ preservation time for the PancreasPak system is up to 21 hours.
Standard method patients
Patients whose donor pancreas was transported with a method other than the PancreasPak device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft dysfunction
Time Frame: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who experience graft dysfunction post-transplant.
Post-transplant through 1 year post-transplant
Pancreatitis
Time Frame: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who experience pancreatitis post-transplant.
Post-transplant through 1 year post-transplant
Primary Non-Function
Time Frame: Post-transplant through 7 days post-transplant
The percentage of subjects in each cohort who primary non-function post transplantation.
Post-transplant through 7 days post-transplant
Length of Hospital Stay
Time Frame: 1 year
How many days the patients stays in the hospital post-transplant.
1 year
Surgical Complications
Time Frame: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who experience surgical complications.
Post-transplant through 1 year post-transplant
Insulin Dependence
Time Frame: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who experience insulin dependence post-transplant.
Post-transplant through 1 year post-transplant
Graft Failure
Time Frame: Post-transplant through 1 year post
The percentage of subjects in each cohort who develop graft failure post-transplant.
Post-transplant through 1 year post
Survival
Time Frame: Post-transplant through 1 year post
The percentage of subjects in each cohort who survive through 1 year post-transplant.
Post-transplant through 1 year post

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of ICU Stay
Time Frame: 1 year
How many days the patient stayed in the ICU post-transplant.
1 year
Interventions for Anastomotic Complications
Time Frame: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who required interventions due to anastomotic complications.
Post-transplant through 1 year post-transplant
Intervention for Vascular Complications
Time Frame: Post-transplant through 1 year-post transplant
The percentage of subjects in each cohort who required interventions due to vascular complications.
Post-transplant through 1 year-post transplant
Medications
Time Frame: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who required the use of various medications.
Post-transplant through 1 year post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paragonix Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

January 1, 2032

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGX-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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