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Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational [Patient Registry]
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04930289
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Paragonix Technologies
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Matthew Hartwig, MD
Principal Investigator Affiliation Duke University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Enrolling by invitation
Countries Belgium, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Interstitial Lung Disease, COPD, Cystic Fibrosis, Pulmonary Fibrosis, Pulmonary Arterial Hypertension, Emphysema
Additional Details

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 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.

Arms & Interventions

Arms

: LungGuard patients

Patients 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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California, San Francisco, San Francisco, California

Status

Address

University of California, San Francisco

San Francisco, California, 94143

Johns Hopkins University, Baltimore, Maryland

Status

Address

Johns Hopkins University

Baltimore, Maryland, 21218

Massachusetts General Hospital, Boston, Massachusetts

Status

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Duke Lung Transplant Clinic, Durham, North Carolina

Status

Address

Duke Lung Transplant Clinic

Durham, North Carolina, 27710

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

Baylor Scott & White Research Institute, Dallas, Texas

Status

Address

Baylor Scott & White Research Institute

Dallas, Texas, 75246

Houston Methodist Hospital, Houston, Texas

Status

Address

Houston Methodist Hospital

Houston, Texas, 77030

University of Virginia, Charlottesville, Virginia

Status

Address

University of Virginia

Charlottesville, Virginia, 22908

International Sites

University Hospitals Leuven, Leuven, Belgium

Status

Address

University Hospitals Leuven

Leuven, , 3000

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