Clinical trial NCT03641677: Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility
Official title: Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases
Keywords: EVLP
ex vivo lung perfusion
organ perfusion
CLES
centralized lung evaluation system
united therapeutics
Lead sponsor: Lung Bioengineering Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-22
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: 12 month survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland Medical System
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Falls Church
country: United States
facility: INOVA Fairfax Hospital
state: Virginia
Study officials:
References: