Interstitial Lung DiseaseGUARDIANLUNGNCT04930289
Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs
An observational study of Interstitial Lung Disease and COPD, run by Paragonix Technologies at 15 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Interstitial Lung Disease, COPD, Cystic Fibrosis
- What is being tested?
- LungGuard and BAROGuard
- Type of treatment
- Medical device
- How many people
- 3,500 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 15 Oct 2021to 30 Dec 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary lung transplant candidates at centers that use the LungGuard device
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 2 countries
United States14 sites
Johns Hopkins University
Baltimore, Maryland, 21218
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Virginia
Charlottesville, Virginia, 22908
Baylor Scott & White Research Institute
Dallas, Texas, 75246
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke Lung Transplant Clinic
Durham, North Carolina, 27710
Houston Methodist Hospital
Houston, Texas, 77030
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Temple University Hospital
Philadelphia, Pennsylvania, 19140
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of California, San Francisco
San Francisco, California, 94143
Stanford Medicine
Stanford, California, 94305
Montefiore Hospital
The Bronx, New York, 10467
About this study
Official title: 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
Read the detailed description
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.
- Conditions
- Interstitial Lung Disease, COPD, Cystic Fibrosis, Pulmonary Fibrosis, Pulmonary Arterial Hypertension, Emphysema
- Being tested
- LungGuard, BAROGuard
- Medical subject headings
- Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive, Cystic Fibrosis, Pulmonary Fibrosis, Pulmonary Arterial Hypertension, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LungGuardDevice
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.
BAROGuardDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| LungGuard patients | Patients whose donor lung(s) was transported with the LungGuard device. Receives: Device: LungGuard | |
| Standard Transport Patients | Patients whose donor lung(s) was transported with a method other than the LungGuard | |
| BAROGuard Patients | Patients whose donor lung(s) was transported with the BAROGuard device. Receives: Device: BAROGuard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Primary Graft Dysfunction (PGD)
The number of subjects that develop PGD after transplant
Measured: Post-transplant through 5 years post
Number of subjects with rejection
Subjects that show signs to rejection after transplant
Measured: Post-transplant through 5 years post
Survival
patient survival post-transplant
Measured: Post-transplant through 5 years post
ICU Length of Stay
Days the subject spent the ICU post-transplant
Measured: Transplant through 5 years post-transplant
Hospital Length of Stay
Days the subject was in the hospital in total after transplant
Measured: Transplant through 5 years post-transplant
Secondary outcomes (2)
Number of rehospitalizations
The number of times the subject was readmitted to the hospital after discharged post-transplant
Measured: 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
Measured: pre-transplant through 48 hours post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start15 Oct 2021
- Primary completion15 Jun 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paragonix Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Hartwig, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930289
- Sponsor's protocol ID
- PGX-004
- Acronym
- GUARDIANLUNG
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2021
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes