Pancreas (Including SPK) TransplantationNCT07487194
Global Utilization And Registry Database for Improved preservAtion of doNor Pancreata (GUARDIAN-PANCREAS)
An observational study of Pancreas (Including SPK) Transplantation and Pancreas Diseases, run by Paragonix Technologies.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreas (Including SPK) Transplantation, Pancreas Diseases, Pancreas Transplant Rejection
- What is being tested?
- PancreasPak
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jan 2032
- 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 pancreas transplant at centers that use the PancreasPak device.
Who may be able to join
- Adult or pediatric recipients of pancreas alone, simultaneous pancreas-kidney, or pancreas after kidney transplant
Who cannot join
- Donor pancreata that do not meet institutional clinical requirements for transplantation
- Simultaneous pancreas-kidney transplant recipients who received donor organs from multiple donors
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Pancreas (Including SPK) Transplantation, Pancreas Diseases, Pancreas Transplant Rejection, Pancreas Transplant; Complications
- Being tested
- PancreasPak
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancreasPakDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PancreasPak patient | Patients whose donor pancreas was transported with the PancreasPak device. Receives: Device: PancreasPak | |
| Standard method patients | Patients whose donor pancreas was transported with a method other than the PancreasPak device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft dysfunction
The percentage of subjects in each cohort who experience graft dysfunction post-transplant.
Measured: Post-transplant through 1 year post-transplant
Pancreatitis
The percentage of subjects in each cohort who experience pancreatitis post-transplant.
Measured: Post-transplant through 1 year post-transplant
Primary Non-Function
The percentage of subjects in each cohort who primary non-function post transplantation.
Measured: Post-transplant through 7 days post-transplant
Length of Hospital Stay
How many days the patients stays in the hospital post-transplant.
Measured: 1 year
Surgical Complications
The percentage of subjects in each cohort who experience surgical complications.
Measured: Post-transplant through 1 year post-transplant
Insulin Dependence
The percentage of subjects in each cohort who experience insulin dependence post-transplant.
Measured: Post-transplant through 1 year post-transplant
Graft Failure
The percentage of subjects in each cohort who develop graft failure post-transplant.
Measured: Post-transplant through 1 year post
Survival
The percentage of subjects in each cohort who survive through 1 year post-transplant.
Measured: Post-transplant through 1 year post
Secondary outcomes (4)
Length of ICU Stay
How many days the patient stayed in the ICU post-transplant.
Measured: 1 year
Interventions for Anastomotic Complications
The percentage of subjects in each cohort who required interventions due to anastomotic complications.
Measured: Post-transplant through 1 year post-transplant
Intervention for Vascular Complications
The percentage of subjects in each cohort who required interventions due to vascular complications.
Measured: Post-transplant through 1 year-post transplant
Medications
The percentage of subjects in each cohort who required the use of various medications.
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 posted23 Mar 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2031 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas (Including SPK) TransplantationStudies 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paragonix Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487194
- Sponsor's protocol ID
- PGX-008
- Status last verified
- Sep 2026
- First submitted
- 17 Mar 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 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 Pancreata (GUARDIAN-PANCREAS)
- ClinicalTrials.gov ID
- NCT07487194
- Acronym / sponsor ID
- PGX-008
- Conditions
- Pancreas (Including SPK) Transplantation, Pancreas Diseases, Pancreas Transplant Rejection, Pancreas Transplant; Complications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Paragonix TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 23 Mar 2026 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PancreasPak patient | – | Device: PancreasPakPatients whose donor pancreas was transported with the PancreasPak device. |
| Standard method patients | – | –Patients whose donor pancreas was transported with a method other than the PancreasPak device. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have received a pancreas transplant at centers that use the PancreasPak device.
Key inclusion criteria (1 listed)
- Adult or pediatric recipients of pancreas alone, simultaneous pancreas-kidney, or pancreas after kidney transplant
Key exclusion criteria (2 listed)
- Donor pancreata that do not meet institutional clinical requirements for transplantation
- Simultaneous pancreas-kidney transplant recipients who received donor organs from multiple 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 |
|---|---|---|
| PancreasPakThe 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. | Device | PancreasPak patient |
Primary outcome
Graft dysfunction
Time frame: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who experience graft dysfunction post-transplant.
Pancreatitis
Time frame: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who experience pancreatitis 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.
Length of Hospital Stay
Time frame: 1 year
How many days the patients stays in the hospital post-transplant.
Surgical Complications
Time frame: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who experience surgical complications.
Insulin Dependence
Time frame: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who experience insulin dependence 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.
Survival
Time frame: Post-transplant through 1 year post
The percentage of subjects in each cohort who survive through 1 year post-transplant.
4 secondary outcomes
Length of ICU Stay
Time frame: 1 year
Interventions for Anastomotic Complications
Time frame: Post-transplant through 1 year post-transplant
Intervention for Vascular Complications
Time frame: Post-transplant through 1 year-post transplant
Medications
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 28 Sep 2026.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas (Including SPK) Transplantation and Pancreas Diseases, run by Paragonix Technologies.
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 1 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: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Amanda Schreiner (781-428-4153 ext. 22, aschreiner@paragonixtechnologies.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft dysfunction (time frame: Post-transplant through 1 year post-transplant). The study lists 8 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 28 Sep 2026.