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Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs (GUARDIANLUNG)

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ClinicalTrials.gov Identifier: NCT04930289
Recruitment Status : Not yet recruiting
First Posted : June 18, 2021
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Paragonix Technologies

Study Description
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Brief 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

Condition or disease Intervention/treatment
Interstitial Lung Disease COPD Cystic Fibrosis Pulmonary Fibrosis Pulmonary Arterial Hypertension Emphysema Device: LungGuard

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 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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Global Utilization and Registry Database for Improved Preservation of Donor Lungs
Estimated Study Start Date : June 15, 2021
Estimated Primary Completion Date : June 15, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
LungGuard patients
Patients whose donor lung(s) was transported with the LungGuard device.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects with Primary Graft Dysfunction (PGD) [ Time Frame: Post-transplant through 1 year post ]
    The number of subjects that develop PGD after transplant

  2. Number of subjects with rejection [ Time Frame: Post-transplant through 1 year post ]
    Subjects that show signs to rejection after transplant

  3. Survival [ Time Frame: Post-transplant through 1 year post ]
    patient survival post-transplant

  4. ICU Length of Stay [ Time Frame: Transplant through 1 year post-transplant ]
    Days the subject spent the ICU post-transplant

  5. Hospital Length of Stay [ Time Frame: Transplant through 1 year post-transplant ]
    Days the subject was in the hospital in total after transplant


Secondary Outcome Measures :
  1. Number of rehospitalizations [ Time Frame: post-transplant through 1 year ]
    The number of times the subject was readmitted to the hospital after discharged post-transplant

  2. How long subjects needed mechanical support [ Time Frame: pre-transplant through 48 hours post-transplant ]
    Amount of time (minutes) mechanical support (EMCO and ventilator) was needed pre and post transplant


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary lung transplant candidates at centers that use the LungGuard device
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04930289


Contacts
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Contact: Julia Hersum 7814284153 ext 4 julia@paragonixtechnologies.com
Contact: Chris Tomosivitch 7813645048 ctomosivitch@paragonixtechnologies.com

Locations
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United States, North Carolina
Duke Lung Transplant Clinic
Durham, North Carolina, United States, 27710
Contact: Sarah Casalinova    919-613-5621    sarah.casalinova@duke.edu   
Principal Investigator: Matthew Hartwig, MD         
Sponsors and Collaborators
Paragonix Technologies
Investigators
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Principal Investigator: Matthew Hartwig, MD Duke University
More Information
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Responsible Party: Paragonix Technologies
ClinicalTrials.gov Identifier: NCT04930289    
Other Study ID Numbers: PGX-004
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Lung Diseases
Pulmonary Fibrosis
Lung Diseases, Interstitial
Hypertension
Fibrosis
Emphysema
Vascular Diseases
 Cardiovascular Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases