Global Utilization And Registry Database for Improved preservAtion of doNor Pancreata (GUARDIAN-P… (NCT07487194) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Global Utilization And Registry Database for Improved preservAtion of doNor Pancreata (GUARDIAN-PANCREAS)
1,000 participantsStarted 2026-06
Plain-language 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. These results will be compared to standard of care outcomes, as well as other preservation methods.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Graft dysfunction
Timeframe: Post-transplant through 1 year post-transplant
2
Pancreatitis
Timeframe: Post-transplant through 1 year post-transplant
3
Primary Non-Function
Timeframe: Post-transplant through 7 days post-transplant
4
Length of Hospital Stay
Timeframe: 1 year
5
Surgical Complications
Timeframe: Post-transplant through 1 year post-transplant
6
Insulin Dependence
Timeframe: Post-transplant through 1 year post-transplant