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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. 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 21, 2020
Sponsor:
Information provided by (Responsible Party):
Lung Bioengineering Inc.

Study Description
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Brief Summary:
The objective of this study is to evaluate the safety and effectiveness of the 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 6 months or hospital discharge post-transplant.

Condition or disease Intervention/treatment Phase
Lung Diseases Device: Centralized Lung Evaluation System Procedure: Lung Transplant Not Applicable

Study Design
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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 : November 1, 2020
Estimated Study Completion Date : June 1, 2021

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 6 month survival [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 cepacia 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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: David Erasmus, MD    904-956-3271    erasmus.david@mayo.edu   
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Mani A Daneshmand, MD    518-253-2155    mani.daneshmand@emory.edu   
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Daniel Dilling, MD    718-526-5402    ddillin@lumc.edu   
United States, Indiana
Indiana University Health Withdrawn
Indianapolis, Indiana, United States, 46202
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, Michigan
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: William Lynch, MD    734-615-3822    wlynch@med.umich.edu   
United States, Missouri
Barnes Jewish Hospital Withdrawn
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Jesus Gomez-Abraham, MD    973-926-8451    Jesus.Gomez-Abraham@rwjbh.org   
United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Zachary Kon, MD    212-263-7185    zachary.kon@nyumc.org   
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Matthew Hartwig, MD    919-613-5635    matthew.hartwig@duke.edu   
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   
Sponsors and Collaborators
Lung Bioengineering Inc.
More Information
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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 21, 2020
Last Verified: May 2020

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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
Keywords provided by Lung Bioengineering Inc.:
EVLP
ex vivo lung perfusion
organ perfusion
 CLES
centralized lung evaluation system
united therapeutics
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases