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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
Assessment of allograft lung for transplant suitability
Orthotopic single or double lung transplantation.
Mayo Clinic Florida
Jacksonville, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
University of Maryland Medical System
Baltimore, Maryland, United States
12 month survival
Time frame: 12 months
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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
...and 3 more locations