Trials / Not Yet Recruiting
Not Yet RecruitingNCT07487194
Global Utilization And Registry Database for Improved preservAtion of doNor Pancreata (GUARDIAN-PANCREAS)
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- Paragonix Technologies · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-06-01
- Primary completion
- 2031-06-01
- Completion
- 2032-01-01
- First posted
- 2026-03-23
- Last updated
- 2026-03-23
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07487194. Inclusion in this directory is not an endorsement.