Summary

Location
at San Francisco, California and other locations
Dates
study start
estimated completion

Description

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

Official Title

Global Utilization and Registry Database for Improved Preservation of Donor Lungs

Details

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.

Keywords

Interstitial Lung Disease, COPD, Cystic Fibrosis, Pulmonary Fibrosis, Pulmonary Arterial Hypertension, Emphysema, Lung Diseases, Interstitial Lung Diseases, Fibrosis, LungGuard

Eligibility

You can join if…

  • Donor and donor lungs matched to the prospective recipient based upon institutional medical practice
  • Registered male or female primary lung transplant candidates including pediatric candidates

You CAN'T join if...

  • Donor and donor lungs that do not meet institutional clinical requirements for transplantation
  • Patients who are incarcerated persons (prisoners)
  • Patients who have had a previous major organ transplant (heart, lungs, liver, kidney, pancreas)
  • Patients who are receiving multiple organ transplants

Locations

  • UCSF
    San Francisco California 94143 United States
  • University of Pittsburgh Medical Center
    Pittsburgh Pennsylvania 15213 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Paragonix Technologies
ID
NCT04930289
Study Type
Observational [Patient Registry]
Participants
Expecting 500 study participants
Last Updated