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

Primary Purpose

Lung Diseases

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Centralized Lung Evaluation System
Lung Transplant
Sponsored by
Lung Bioengineering Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases focused on measuring EVLP, ex vivo lung perfusion, organ perfusion, CLES, centralized lung evaluation system, united therapeutics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Florida
  • Emory University Hospital
  • University of Maryland Medical System
  • Johns Hopkins Hospital
  • Brigham and Women's Hospital
  • University of Michigan Medical Center
  • Spectrum Health
  • Newark Beth Israel Medical Center
  • NYU Langone Health
  • Duke University Medical Center
  • Cleveland Clinic
  • Vanderbilt University
  • INOVA Fairfax Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EVLP

Control

Arm Description

Outcomes

Primary Outcome Measures

12 month survival

Secondary Outcome Measures

Full Information

First Posted
August 20, 2018
Last Updated
May 31, 2023
Sponsor
Lung Bioengineering Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03641677
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
December 26, 2023 (Anticipated)
Study Completion Date
March 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lung Bioengineering Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
Keywords
EVLP, ex vivo lung perfusion, organ perfusion, CLES, centralized lung evaluation system, united therapeutics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EVLP
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Centralized Lung Evaluation System
Intervention Description
Assessment of allograft lung for transplant suitability
Intervention Type
Procedure
Intervention Name(s)
Lung Transplant
Intervention Description
Orthotopic single or double lung transplantation.
Primary Outcome Measure Information:
Title
12 month survival
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Maryland Medical System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
INOVA Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States

12. IPD Sharing Statement

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

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