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

Purpose

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

  • Lung Diseases

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Maryland Medical System
Baltimore, Maryland 21201
Contact:
Bartley Griffith, MD
410-328-2760
BGriffith@som.umaryland.edu

More Details

NCT ID
NCT03641677
Status
Recruiting
Sponsor
Lung Bioengineering Inc.

Study Contact