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Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs — GUARDIANLUNG  

Cystic Fibrosis Clinical Trial

Official title:
Global Utilization and Registry Database for Improved Preservation of Donor Lungs

Clinical Trial Summary

The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor lung that were preserved and transported within the LUNGguard system, as well as retrospective standard of care patients

Clinical Trial Description

GUARDIAN-Lung is a post-market, observational registry of adult and pediatric lung transplant recipient patients whose donor lungs was preserved and transported within the LUNGguard. 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 500 male and female subjects (including pediatric patients) meeting the study inclusion and exclusion criteria will be enrolled into the study at about 5 clinical sites. Candidates that fit the eligibility criteria and have had their donor lungs 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04930289
Study type Observational [Patient Registry]
Source Paragonix Technologies
Contact
Status Enrolling by invitation
Phase
Start date October 15, 2021
Completion date December 30, 2025
View Details
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