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Could a lung 'Second Look' system expand the donor pool?

NCT ID NCT03641677

Disease control Sponsor: Lung Bioengineering Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial tests a system that evaluates donor lungs outside the body to see if they are suitable for transplant. The goal is to increase the number of lungs available for people with severe, life-limiting lung disease who are waiting for a transplant. Participants are adults already on the lung transplant waiting list who receive a donor lung that has been assessed with this system. Researchers will track survival at 12 months after transplant to see if the approach is safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Centralized Lung Evaluation System, a device that assesses donor lungs outside the body to determine if they are suitable for transplant
What this could lead to
If it works, this could make more donor lungs available for transplant, potentially reducing wait times and saving lives of people with severe lung disease.
What could go wrong
The trial is still testing safety and effectiveness, and it is unclear whether lungs evaluated this way will perform as well as standard donor lungs. There are also risks associated with any lung transplant surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

174 people

The number who actually took part.

Started

Apr 2019

Finished

Jan 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

lung disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung diseases

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • INOVA Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112, United States

  • Spectrum Health

    Grand Rapids, Michigan, 49503, United States

  • University of Maryland Medical System

    Baltimore, Maryland, 21201, United States

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109, United States

  • Vanderbilt University

    Nashville, Tennessee, 37204, United States

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