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NOT YET RECRUITING
NCT07487194

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

Sponsor: Paragonix Technologies

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2026-06

Completion Date

2032-01

Last Updated

2026-03-23

Healthy Volunteers

No

Conditions

Pancreas (Including SPK) TransplantationPancreas DiseasesPancreas Transplant RejectionPancreas Transplant; Complications

Interventions

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.