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

Sponsor

Lung Bioengineering Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03641677

Collaborator

(none)

186

Enrollment

Locations

Arms

48.6

Anticipated Duration (Months)

13.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Diseases	Device: Centralized Lung Evaluation System Procedure: Lung Transplant	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 15, 2019

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

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.

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

Primary Outcome Measures

12 month survival [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Florida	Jacksonville	Florida	United States	32224
2	Emory University Hospital	Atlanta	Georgia	United States	30322
3	Loyola University Medical Center	Maywood	Illinois	United States	60153
4	University of Maryland Medical System	Baltimore	Maryland	United States	21201
5	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
6	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
7	University of Michigan Medical Center	Ann Arbor	Michigan	United States	48109
8	Spectrum Health	Grand Rapids	Michigan	United States	49503
9	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112
10	NYU Langone Health	New York	New York	United States	10016
11	Duke University Medical Center	Durham	North Carolina	United States	27710
12	Cleveland Clinic	Cleveland	Ohio	United States	44195
13	Vanderbilt University	Nashville	Tennessee	United States	37204
14	INOVA Fairfax Hospital	Falls Church	Virginia	United States	22042