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Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility
Sponsor: Lung Bioengineering Inc.
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
Centralized Lung Evaluation System
Assessment of allograft lung for transplant suitability
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