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Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility

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ClinicalTrials.gov Identifier: NCT03641677
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Lung Bioengineering Inc.

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

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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

Resource links provided by the National Library of Medicine


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.




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

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, Indiana
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jose Garcia, MD    317-962-9700    jgarcia9@iuhealth.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   
Sponsors and Collaborators
Lung Bioengineering Inc.

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Responsible Party: Lung Bioengineering Inc.
ClinicalTrials.gov Identifier: NCT03641677     History of Changes
Other Study ID Numbers: EVP-DEV-LTX-301
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

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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