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COMPLETED
NCT03641677
NA

Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility

Sponsor: Lung Bioengineering Inc.

View on ClinicalTrials.gov

Summary

The objective of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end stage, survival-limiting lung disease in need of lung transplantation. This will be accomplished by evaluating subject survival at the later of 12 months or hospital discharge post-transplant.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

174

Start Date

2019-04-21

Completion Date

2024-01-18

Last Updated

2026-09-03

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Centralized Lung Evaluation System

Assessment of allograft lung for transplant suitability

PROCEDURE

Lung Transplant

Orthotopic single or double lung transplantation.

Locations (13)

Mayo Clinic Florida

Jacksonville, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

University of Maryland Medical System

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Spectrum Health

Grand Rapids, Michigan, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

NYU Langone Health

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Vanderbilt University

Nashville, Tennessee, United States

INOVA Fairfax Hospital

Falls Church, Virginia, United States