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

Lung Biotechnology

Status

Completed

Conditions

Lung Diseases

Treatments

Device: Centralized Lung Evaluation System

Procedure: Lung Transplant

Study type

Interventional

Funder types

Industry

Identifiers

NCT03641677

EVP-DEV-LTX-301

Details and patient eligibility

About

The objective of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (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 12 months or hospital discharge post-transplant.

Enrollment

174 patients

Sex

All

Ages

18+ years old

Volunteers

No 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