Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility
1 other identifier
interventional
174
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2018
CompletedFirst Posted
Study publicly available on registry
August 22, 2018
CompletedStudy Start
First participant enrolled
January 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2024
CompletedNovember 12, 2024
November 1, 2024
4.9 years
August 20, 2018
November 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
12 month survival
12 months
Study Arms (2)
EVLP
EXPERIMENTALControl
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
University of Maryland Medical System
Baltimore, Maryland, 21201, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Spectrum Health
Grand Rapids, Michigan, 49503, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
NYU Langone Health
New York, New York, 10016, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Vanderbilt University
Nashville, Tennessee, 37204, United States
INOVA Fairfax Hospital
Falls Church, Virginia, 22042, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2018
First Posted
August 22, 2018
Study Start
January 15, 2019
Primary Completion
December 18, 2023
Study Completion
January 18, 2024
Last Updated
November 12, 2024
Record last verified: 2024-11