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

Paragonix Technologies

Status: Begins enrollment in 1 month

Conditions: Pancreas Transplant Rejection; Pancreas Diseases; Pancreas Transplant; Complications; Pancreas (Including SPK) Transplantation

Treatments: Device: PancreasPak

Study type: Observational

Funder types: Industry

Identifiers

NCT07487194

PGX-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 2 patient groups

PancreasPak patient

Description:

Patients whose donor pancreas was transported with the PancreasPak device.

Treatment:

Device: PancreasPak

Standard method patients

Description:

Patients whose donor pancreas was transported with a method other than the PancreasPak device.