Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility
- Conditions
- Lung Diseases
- Interventions
- Device: Centralized Lung Evaluation SystemProcedure: Lung Transplant
- Registration Number
- NCT03641677
- Lead Sponsor
- Lung Bioengineering Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
- Male or female;
- Aged 18 years or older;
- Informed consent is given for participation in the Study by the patient or patient's designated representative; and
- Patient undergoes lung transplantation.
- Patients listed for same-side lung re-transplantation.
- Patients listed for multiple organ transplantation including lung and any other organ.
- Patients listed for live donor lobar lung transplant.
- Patients positive for human immunodeficiency virus (HIV) or Burkholderia cenocepacia infection.
- Patient receives a standard of care (non-EVLP) lung transplant but does not match to an EVLP subject based on the criteria for control matching.
- Participating in another interventional trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EVLP Lung Transplant - EVLP Centralized Lung Evaluation System - Control Lung Transplant -
- Primary Outcome Measures
Name Time Method 12 month survival 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
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
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
NYU Langone Health
🇺🇸New York, New York, United States
INOVA Fairfax Hospital
🇺🇸Falls Church, Virginia, United States