Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs
NCT ID: NCT04930289
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
2000 participants
OBSERVATIONAL
2021-10-15
2029-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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LungGuard patients
Patients whose donor lung(s) was transported with the LungGuard device.
LungGuard
The LUNGguard is an FDA cleared and is a CE-marked medical device intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs. The intended organ storage time for the LUNGguard is up to 8 hours.
Standard Transport Patients
Patients whose donor lung(s) was transported with a method other than the LungGuard
No interventions assigned to this group
BAROGuard Patients
Patients whose donor lung(s) was transported with the BAROGuard device.
BAROGuard
The BAROguard (the "System") is ultraportable hypothermic preservation and transport system intended for use with donor lungs. BAROguard is a legally marketed, FDA cleared medical device in the United States. The intended organ storage time for BAROguard™ is up to 8 hours.
Interventions
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LungGuard
The LUNGguard is an FDA cleared and is a CE-marked medical device intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs. The intended organ storage time for the LUNGguard is up to 8 hours.
BAROGuard
The BAROguard (the "System") is ultraportable hypothermic preservation and transport system intended for use with donor lungs. BAROguard is a legally marketed, FDA cleared medical device in the United States. The intended organ storage time for BAROguard™ is up to 8 hours.
Eligibility Criteria
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Inclusion Criteria
* Registered male or female primary lung transplant candidates including pediatric candidates
Exclusion Criteria
* 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
ALL
No
Sponsors
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Paragonix Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Matthew Hartwig, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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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
Baylor Scott & White Research Institute
Dallas, Texas, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
University Hospitals Leuven
Leuven, , Belgium
Countries
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Other Identifiers
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PGX-004
Identifier Type: -
Identifier Source: org_study_id
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