Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs
Launched by PARAGONIX TECHNOLOGIES · Jun 15, 2021
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • 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
About Paragonix Technologies
Paragonix Technologies is a pioneering medical device company specializing in advanced organ preservation solutions to enhance transplant outcomes. With a focus on innovative technologies, Paragonix develops cutting-edge systems that ensure the safe and efficient transport of donor organs, thereby improving the viability and success rates of transplants. Committed to transforming the field of transplantation, the company collaborates with healthcare professionals and institutions to deliver products that address critical challenges in organ preservation and transportation, ultimately aiming to save lives and improve patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
San Francisco, California, United States
Charlottesville, Virginia, United States
Jacksonville, Florida, United States
Phoenix, Arizona, United States
Pittsburgh, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Bronx, New York, United States
Baltimore, Maryland, United States
Leuven, , Belgium
Dallas, Texas, United States
Stanford, California, United States
Boston, Massachusetts, United States
Dallas, Texas, United States
Durham, North Carolina, United States
Patients applied
Trial Officials
Matthew Hartwig, MD
Principal Investigator
Duke University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials