Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs

NCT04930289 | Enrolling By Invitation FDA Device

• 1 other identifier: PGX-004
• Study Type: observational
• Target: 2,000
• Locations: 2 countries
• Sites: 15

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

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Number of subjects with Primary Graft Dysfunction (PGD)

  The number of subjects that develop PGD after transplant

  Post-transplant through 1 year post

• Number of subjects with rejection

  Subjects that show signs to rejection after transplant

  Post-transplant through 1 year post

• Survival

  patient survival post-transplant

  Post-transplant through 1 year post

• ICU Length of Stay

  Days the subject spent the ICU post-transplant

  Transplant through 1 year post-transplant

• Hospital Length of Stay

  Days the subject was in the hospital in total after transplant

  Transplant through 1 year post-transplant

Secondary Outcomes (2)

• Number of rehospitalizations

  post-transplant through 1 year

• How long subjects needed mechanical support

  pre-transplant through 48 hours post-transplant

Study Arms (3)

LungGuard patients

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

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.

Device: BAROGuard

Interventions

LungGuard DEVICE

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.

LungGuard patients

BAROGuard DEVICE

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.

BAROGuard Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary lung transplant candidates at centers that use the LungGuard device

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paragonix Technologies: lead

Study Sites (15)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Stanford Medicine

Stanford, California, 94305, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Montefiore Hospital

The Bronx, New York, 10467, United States

Location

Duke Lung Transplant Clinic

Durham, North Carolina, 27710, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor Scott & White Research Institute

Dallas, Texas, 75246, United States

Location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

University Hospitals Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial; Pulmonary Disease, Chronic Obstructive; Cystic Fibrosis; Pulmonary Fibrosis; Pulmonary Arterial Hypertension; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Fibrosis; Hypertension, Pulmonary

Study Officials

• Matthew Hartwig, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 18, 2021
• Study Start: October 15, 2021
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

BE (1); US (14)