NCT03641677

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

April 21, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2024

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

September 3, 2026

Completed
Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

4.7 years

First QC Date

August 20, 2018

Results QC Date

July 21, 2026

Last Update Submit

August 13, 2026

Conditions

Lung Diseases

Keywords

EVLPex vivo lung perfusionorgan perfusionCLEScentralized lung evaluation systemunited therapeutics

Outcome Measures

Primary Outcomes (1)

  • 12 Month Survival or Freedom From Mortality

    Survival at 12 months following lung transplantation

    12 Months

Study Arms (2)

EVLP

EXPERIMENTAL
Device: Centralized Lung Evaluation SystemProcedure: Lung Transplant

Control

ACTIVE COMPARATOR
Procedure: Lung Transplant

Interventions

Centralized Lung Evaluation SystemDEVICE

Assessment of allograft lung for transplant suitability

EVLP
Lung TransplantPROCEDURE

Orthotopic single or double lung transplantation.

ControlEVLP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Each patient must meet all of the following criteria to be enrolled in the Study: 1. 18 years of age or older. 2. Male or female. 3. Patient actively awaiting a single or double lung transplant. 4. Patient or patient's representative provides informed consent for participation in the study prior to participating in any study-related assessments or procedures. 5. 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: 1. Patients listed for same-side lung re-transplantation. 2. Patients listed for multiple organ transplantation including lung and any other organ. 3. Patients listed for live donor lobar lung transplant. 4. Patients positive for human immunodeficiency virus (HIV ) or Burkholderia cenocepacia infection. 5. 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. 6. Transplanted with a lung that was perfused using another EVLP technology. 7. Participating in another respiratory or cardiovascular clinical trial.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (13)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

University of Maryland Medical System

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Vanderbilt University

Nashville, Tennessee, 37204, United States

Location

INOVA Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

Lung Transplantation

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pulmonary Surgical ProceduresThoracic Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Results Point of Contact

Title
Michael Roberts
Organization
Lung Bioengineering, Inc.
mroberts@lungbioengineering.com
(240) 650-2261

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2018

First Posted

August 22, 2018

Study Start

April 21, 2019

Primary Completion

December 18, 2023

Study Completion

January 18, 2024

Last Updated

September 3, 2026

Results First Posted

September 3, 2026

Record last verified: 2026-08

Locations

US(13)