Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03641677 |
Recruitment Status :
Recruiting
First Posted : August 22, 2018
Last Update Posted : May 17, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Diseases | Device: Centralized Lung Evaluation System Procedure: Lung Transplant | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 186 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 : | January 1, 2023 |
Estimated Study Completion Date : | February 1, 2023 |

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 ]

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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
Contact: Michael Roberts | 2406502261 | mroberts@lungbioengineering.com |
United States, Florida | |
Mayo Clinic Florida | Recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact: Si Pham, MD 904-956-3212 pham.si@mayo.edu | |
United States, Georgia | |
Emory University Hospital | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Mani A Daneshmand, MD 404-712-2117 mani.daneshmand@emory.edu | |
United States, Illinois | |
Loyola University Medical Center | Withdrawn |
Maywood, Illinois, United States, 60153 | |
United States, Maryland | |
University of Maryland Medical System | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Bartley Griffith, MD 410-328-2760 BGriffith@som.umaryland.edu | |
Johns Hopkins Hospital | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Errol Bush, MD 410-614-3892 errol.bush@jhu.edu | |
United States, Massachusetts | |
Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Antonio Coppolino, MD 617-525-8704 acoppolino@bwh.harvard.edu | |
United States, Michigan | |
University of Michigan Medical Center | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: William Lynch, MD 734-615-3822 wlynch@med.umich.edu | |
Spectrum Health | Recruiting |
Grand Rapids, Michigan, United States, 49503 | |
Contact: Edward Murphy, MD 616-459-7258 edward.murphy@spectrumhealth.org | |
United States, New Jersey | |
Newark Beth Israel Medical Center | Recruiting |
Newark, New Jersey, United States, 07112 | |
Contact: Jesus Gomez-Abraham, MD 973-926-6938 Jesus.Gomez-Abraham@rwjbh.org | |
United States, New York | |
NYU Langone Health | Completed |
New York, New York, United States, 10016 | |
United States, North Carolina | |
Duke University Medical Center | Active, not recruiting |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Kenneth McCurry, MD 216-445-9303 mccurrk@ccf.org | |
United States, Tennessee | |
Vanderbilt University | Recruiting |
Nashville, Tennessee, United States, 37204 | |
Contact: Matthew Bacchetta, MD 615-981-0584 matthew.bacchetta@vanderbilt.edu | |
United States, Virginia | |
INOVA Fairfax Hospital | Recruiting |
Falls Church, Virginia, United States, 22042 | |
Contact: Anne Brown, MD 703-776-3156 Anne.Brown@inova.org |
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: | May 17, 2022 |
Last Verified: | May 2022 |
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 |