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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Utilization and Registry Database for Improved Preservation of Donor Lungs
- ClinicalTrials.gov ID
- NCT04930289
- Acronym / sponsor ID
- GUARDIANLUNG / PGX-004
- Conditions
- Interstitial Lung Disease, COPD, Cystic Fibrosis, Pulmonary Fibrosis, Pulmonary Arterial Hypertension, Emphysema
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Paragonix TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LungGuard patients | – | Device: LungGuardPatients whose donor lung(s) was transported with the LungGuard device. |
| Standard Transport Patients | – | –Patients whose donor lung(s) was transported with a method other than the LungGuard |
| BAROGuard Patients | – | Device: BAROGuardPatients whose donor lung(s) was transported with the BAROGuard device. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary lung transplant candidates at centers that use the LungGuard device
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LungGuardThe 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. | Device | LungGuard patients |
| BAROGuardThe 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. | Device | BAROGuard Patients |
Primary outcome
Number of subjects with Primary Graft Dysfunction (PGD)
Time frame: Post-transplant through 5 years post
The number of subjects that develop PGD after transplant
Number of subjects with rejection
Time frame: Post-transplant through 5 years post
Subjects that show signs to rejection after transplant
Survival
Time frame: Post-transplant through 5 years post
patient survival post-transplant
ICU Length of Stay
Time frame: Transplant through 5 years post-transplant
Days the subject spent the ICU post-transplant
Hospital Length of Stay
Time frame: Transplant through 5 years post-transplant
Days the subject was in the hospital in total after transplant
2 secondary outcomes
Number of rehospitalizations
Time frame: post-transplant through 1 year
How long subjects needed mechanical support
Time frame: pre-transplant through 48 hours post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Hartwig, MD principal investigator
Duke University
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease and COPD, run by Paragonix Technologies at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with Primary Graft Dysfunction (PGD) (time frame: Post-transplant through 5 years post). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.