Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03641677 |
Recruitment Status :
Active, not recruiting
First Posted : August 22, 2018
Last Update Posted : June 1, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Diseases | Device: Centralized Lung Evaluation System Procedure: Lung Transplant | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 174 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility |
Actual Study Start Date : | January 15, 2019 |
Estimated Primary Completion Date : | December 26, 2023 |
Estimated Study Completion Date : | March 18, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: EVLP |
Device: Centralized Lung Evaluation System
Assessment of allograft lung for transplant suitability Procedure: Lung Transplant Orthotopic single or double lung transplantation. |
Active Comparator: Control |
Procedure: Lung Transplant
Orthotopic single or double lung transplantation. |
- 12 month survival [ Time Frame: 12 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641677
United States, Florida | |
Mayo Clinic Florida | |
Jacksonville, Florida, United States, 32224 | |
United States, Georgia | |
Emory University Hospital | |
Atlanta, Georgia, United States, 30322 | |
United States, Maryland | |
University of Maryland Medical System | |
Baltimore, Maryland, United States, 21201 | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
University of Michigan Medical Center | |
Ann Arbor, Michigan, United States, 48109 | |
Spectrum Health | |
Grand Rapids, Michigan, United States, 49503 | |
United States, New Jersey | |
Newark Beth Israel Medical Center | |
Newark, New Jersey, United States, 07112 | |
United States, New York | |
NYU Langone Health | |
New York, New York, United States, 10016 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37204 | |
United States, Virginia | |
INOVA Fairfax Hospital | |
Falls Church, Virginia, United States, 22042 |
Responsible Party: | Lung Bioengineering Inc. |
ClinicalTrials.gov Identifier: | NCT03641677 |
Other Study ID Numbers: |
EVP-DEV-LTX-301 |
First Posted: | August 22, 2018 Key Record Dates |
Last Update Posted: | June 1, 2023 |
Last Verified: | May 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
EVLP ex vivo lung perfusion organ perfusion |
CLES centralized lung evaluation system united therapeutics |
Lung Diseases Respiratory Tract Diseases |