Pivotal Clinical Study Protocol

Study Description

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 after transplant.

ClinicalTrials.gov
Identifier: NCT 03641677

For additional information, please visit
https://clinicaltrials.gov/ct2/show/NCT03641677

Study Design

16

TRANSPLANT
CENTER STUDY
SITES​

150 patients

EVLP Group

75

Control Group

75

Study Objectives

Primary Endpoint

12 months survival

Secondary ENDPOINTs

Subject survival at

30 Days

90 Days

6 Months

Primary Graft Dysfunction (PGD) score (grades 0-3) measured at

PGD

0 HR

24 hr

48 hr

72 hr

Post-transplant

Time to first extubation

Rate of ECMO use post-transplant

ICU Length Of Stay (LOS)

Hospital LOS

Rate of Chronic Lung Allograft Dysfunction (CLAD)

Rate of respiratory failure

FEV₁ values at follow-up visits

Assessment of adverse events

Data will also be collected on patients who receive a conventional lung transplant. These patients will be enrolled in a contemporaneous control group in order to provide context for EVLP results.

Utilization rate

Increase in use of donor lungs

total Preservation time (TPT)

What is CLES?

The objective of the 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 transplantation.