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Can Device-Preserved donor lungs boost transplant success?

NCT ID NCT04930289

Disease control Sponsor: Paragonix Technologies 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 18, 2026 · Last updated Sep 18, 2026

Summary

This registry collects data on lung transplant patients whose donor lungs were preserved and transported using the LUNGguard or BAROguard devices. Researchers track outcomes such as primary graft dysfunction, rejection, survival, ICU and hospital stays, readmissions, and time on mechanical support. The study includes pediatric and adult lung transplant candidates and compares device-preserved lungs with standard care. The goal is to evaluate how well these preservation methods perform in real-world transplant settings.

What this could mean

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

Active substance
LUNGguard and BAROguard donor lung preservation and transport devices
What this could lead to
If these devices preserve donor lungs well, more lungs could reach transplant patients in good condition, potentially improving outcomes and expanding the supply of usable organs.
What could go wrong
This is an observational registry, not a randomized trial, so it cannot prove the devices cause better outcomes. Results may be confounded by differences in patients, donors, and hospital practices, and the findings may not apply everywhere.

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.

Participants

About 3,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Dec 2029

An estimate. End dates often move.

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.

Who is studied

Primary lung transplant candidates at centers that use the LungGuard device

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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.

Inclusion Criteria: * Donor and donor lungs matched to the prospective recipient based upon institutional medical practice * Registered male or female primary lung transplant candidates including pediatric candidates Exclusion Criteria: * Donor and donor lungs that do not meet institutional clinical requirements for transplantation * Patients who are incarcerated persons (prisoners) * Patients who have had a previous major organ transplant (heart, lungs, liver, kidney, pancreas) * Patients who are receiving multiple organ transplants

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset cystic fibrosis interstitial lung disease pulmonary arterial hypertension pulmonary emphysema pulmonary fibrosis

As listed by the trial registrant

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

COPD Cystic fibrosis Emphysema Interstitial lung disease Pulmonary arterial hypertension Pulmonary fibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75246, United States

  • Duke Lung Transplant Clinic

    Durham, North Carolina, 27710, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21218, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • Montefiore Hospital

    The Bronx, New York, 10467, United States

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013, United States

  • Stanford Medicine

    Stanford, California, 94305, United States

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140, United States

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University Hospitals Leuven

    Leuven, 3000, Belgium

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

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