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

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.

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Key information

Conditions

Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Florida, Jacksonville, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Each patient must meet all of the following criteria to be enrolled in the Study:

18 years of age or older.
Male or female.
Patient actively awaiting a single or double lung transplant.
Patient or patient's representative provides informed consent for participation in the study prior to participating in any study-related assessments or procedures.
Patient matches with and undergoes a transplant with a donor lung.

Patients who meet any of the following criteria will be excluded from the study:

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.
Transplanted with a lung that was perfused using another EVLP technology.
Participating in another respiratory or cardiovascular clinical trial.

Treatment and study plan

Centralized Lung Evaluation System

Device

Assessment of allograft lung for transplant suitability

Lung Transplant

Procedure

Orthotopic single or double lung transplantation.

Primary outcomes

12 Month Survival or Freedom From Mortality

Time frame: 12 Months

Survival at 12 months following lung transplantation

Sponsors and collaborators

Lead sponsor

Lung Bioengineering Inc.

Industry

Registry information

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2024
First posted: Aug 22, 2018
Registry last updated: Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed