NCT Number: NCT07487194
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.
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Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who experience graft dysfunction post-transplant.
Time frame: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who experience pancreatitis post-transplant.
Time frame: Post-transplant through 7 days post-transplant
The percentage of subjects in each cohort who primary non-function post transplantation.
Time frame: 1 year
How many days the patients stays in the hospital post-transplant.
Time frame: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who experience surgical complications.
Time frame: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who experience insulin dependence post-transplant.
Time frame: Post-transplant through 1 year post
The percentage of subjects in each cohort who develop graft failure post-transplant.
Time frame: Post-transplant through 1 year post
The percentage of subjects in each cohort who survive through 1 year post-transplant.
Time frame: 1 year
How many days the patient stayed in the ICU post-transplant.
Time frame: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who required interventions due to anastomotic complications.
Time frame: Post-transplant through 1 year-post transplant
The percentage of subjects in each cohort who required interventions due to vascular complications.
Time frame: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who required the use of various medications.
Contact information is provided by the study sponsor or research team.
Paragonix Technologies
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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