An observational study in Interstitial Lung Disease, COPD and Cystic Fibrosis, sponsored by Paragonix Technologies. Enrolling by invitation at 15 sites in 2 countries. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Paragonix Technologies · Observational
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 3,500 male and female subjects (including pediatric patients) meeting the study inclusion and exclusion criteria will be enrolled into the study at about 25 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.
342 studies on the registry are indexed under Pulmonary Fibrosis; 98 are open to participants now.
This study's planned enrollment of 3,500 is above the median of 150 across 118 observational studies indexed under Pulmonary Fibrosis.
Browse Pulmonary Fibrosis studies →Paragonix Technologies is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Compared within Pulmonary Fibrosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lung Diseases, Interstitial. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Primary lung transplant candidates at centers that use the LungGuard device
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients whose donor lung(s) was transported with the LungGuard device.
Device: LungGuard
Patients whose donor lung(s) was transported with a method other than the LungGuard
Patients whose donor lung(s) was transported with the BAROGuard device.
Device: BAROGuard
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.
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.
Number of subjects with Primary Graft Dysfunction (PGD)
The number of subjects that develop PGD after transplant
Time frame: Post-transplant through 5 years post
Number of subjects with rejection
Subjects that show signs to rejection after transplant
Time frame: Post-transplant through 5 years post
Survival
patient survival post-transplant
Time frame: Post-transplant through 5 years post
ICU Length of Stay
Days the subject spent the ICU post-transplant
Time frame: Transplant through 5 years post-transplant
Hospital Length of Stay
Days the subject was in the hospital in total after transplant
Time frame: Transplant through 5 years post-transplant
Number of rehospitalizations
The number of times the subject was readmitted to the hospital after discharged post-transplant
Time frame: post-transplant through 1 year
How long subjects needed mechanical support
Amount of time (minutes) mechanical support (EMCO and ventilator) was needed pre and post transplant
Time frame: pre-transplant through 48 hours post-transplant
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Paragonix Technologies