Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    500
  • sponsor
    Paragonix Technologies
Updated on 8 October 2021
COPD
lung transplant

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

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.

Details
Condition Lung Disease, Emphysema, Pancreatic Disorders, Pulmonary Disease, Pancreatic disorder, Reactive Airway Disease, chronic obstructive pulmonary disease (copd), Chronic Obstructive Lung Disease, COPD, Pulmonary Fibrosis, interstitial lung diseases, COPD (Chronic Obstructive Pulmonary Disease), Interstitial lung disease, Pulmonary Arterial Hypertension, Cystic Fibrosis, chronic obstructive pulmonary disease, lung fibrosis
Treatment LungGuard
Clinical Study IdentifierNCT04930289
SponsorParagonix Technologies
Last Modified on8 October 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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