Lung DiseasesNCT03641677
Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility
A study testing Centralized Lung Evaluation System and Lung Transplant in people with Lung Diseases, run by Lung Bioengineering Inc. at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Centralized Lung Evaluation System and Lung Transplant
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 13 sitesUnited States
- Study dates
- 21 Apr 2019to 18 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Emory University Hospital
Atlanta, Georgia, 30322
University of Maryland Medical System
Baltimore, Maryland, 21201
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
INOVA Fairfax Hospital
Falls Church, Virginia, 22042
Spectrum Health
Grand Rapids, Michigan, 49503
Mayo Clinic Florida
Jacksonville, Florida, 32224
Vanderbilt University
Nashville, Tennessee, 37204
NYU Langone Health
New York, New York, 10016
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
About this study
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.
- Conditions
- Lung Diseases
- Being tested
- Centralized Lung Evaluation System, Lung Transplant
- Keywords
- EVLP, ex vivo lung perfusion, organ perfusion, CLES, centralized lung evaluation system, united therapeutics
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centralized Lung Evaluation SystemDevice
Assessment of allograft lung for transplant suitability
Lung TransplantProcedure or surgery
Orthotopic single or double lung transplantation.
| Study group | Role | What they receive |
|---|---|---|
| EVLP | Experimental | Not described Receives: Device: Centralized Lung Evaluation System; Procedure: Lung Transplant |
| Control | Active comparator | Not described Receives: Procedure: Lung Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 Month Survival or Freedom From Mortality
Survival at 12 months following lung transplantation
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start21 Apr 2019
- Primary completion18 Dec 2023
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lung Bioengineering Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641677
- Sponsor's protocol ID
- EVP-DEV-LTX-301
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2018
- Last updated
- 3 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility
- ClinicalTrials.gov ID
- NCT03641677
- Acronym / sponsor ID
- EVP-DEV-LTX-301
- Conditions
- Lung Diseases
- Keywords
- EVLP, ex vivo lung perfusion, organ perfusion, CLES, centralized lung evaluation system, united therapeutics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Lung Bioengineering Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2019 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Posted 3 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVLP | Experimental | Device: Centralized Lung Evaluation System, Procedure: Lung Transplant |
| Control | Active comparator | Procedure: Lung Transplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Centralized Lung Evaluation SystemAssessment of allograft lung for transplant suitability | Device | EVLP |
| Lung TransplantOrthotopic single or double lung transplantation. | Procedure or surgery | Control, EVLP |
Primary outcome
12 Month Survival or Freedom From Mortality
Time frame: 12 Months
Survival at 12 months following lung transplantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Centralized Lung Evaluation System and Lung Transplant in people with Lung Diseases, run by Lung Bioengineering Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12 Month Survival or Freedom From Mortality (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.