Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07487194
Brief 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.
Study:
NCT07487194
Study Brief:
Protocol Section:
NCT07487194