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

Paragonix Technologies

Status: Invitation-only

Conditions: Pulmonary Fibrosis; Emphysema; Cystic Fibrosis; COPD; Pulmonary Arterial Hypertension; Interstitial Lung Disease

Treatments: Device: BAROGuard; Device: LungGuard

Study type: Observational

Funder types: Industry

Identifiers

NCT04930289

PGX-004

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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 design

2,000 participants in 3 patient groups

LungGuard patients

Description:

Patients whose donor lung(s) was transported with the LungGuard device.

Treatment:

Device: LungGuard

Standard Transport Patients

Description:

Patients whose donor lung(s) was transported with a method other than the LungGuard

BAROGuard Patients

Description:

Patients whose donor lung(s) was transported with the BAROGuard device.

Treatment:

Device: BAROGuard