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ENROLLING BY INVITATION
NCT04930289

Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs

Sponsor: Paragonix Technologies

View on ClinicalTrials.gov

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

Official title: Global Utilization and Registry Database for Improved Preservation of Donor Lungs

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2021-10-15

Completion Date

2029-12-30

Last Updated

2025-05-15

Healthy Volunteers

No

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.

DEVICE

BAROGuard

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.

Locations (15)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

University of California, San Francisco

San Francisco, California, United States

Stanford Medicine

Stanford, California, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Montefiore Hospital

The Bronx, New York, United States

Duke Lung Transplant Clinic

Durham, North Carolina, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Baylor Scott & White Research Institute

Dallas, Texas, United States

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

University Hospitals Leuven

Leuven, Belgium