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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2024-01-18

Brief Summary

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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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Detailed Description

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Conditions

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Lung Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EVLP

Group Type EXPERIMENTAL

Centralized Lung Evaluation System

Intervention Type DEVICE

Assessment of allograft lung for transplant suitability

Lung Transplant

Intervention Type PROCEDURE

Orthotopic single or double lung transplantation.

Control

Group Type ACTIVE_COMPARATOR

Lung Transplant

Intervention Type PROCEDURE

Orthotopic single or double lung transplantation.

Interventions

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Centralized Lung Evaluation System

Assessment of allograft lung for transplant suitability

Intervention Type DEVICE

Lung Transplant

Orthotopic single or double lung transplantation.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No