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Global Utilization and Registry Database for Improved Preservation of Donor Lungs
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
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
University of California, San Francisco
San Francisco, California, United States
Stanford Medicine
Stanford, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Montefiore Hospital
The Bronx, New York, United States
Duke Lung Transplant Clinic
Durham, North Carolina, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Start Date
October 15, 2021
Primary Completion Date
June 15, 2028
Completion Date
December 30, 2029
Last Updated
May 15, 2025
2,000
ESTIMATED participants
LungGuard
DEVICE
BAROGuard
DEVICE
Lead Sponsor
Paragonix Technologies
NCT07484243
NCT02417740
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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