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Massive registry launched to monitor lung transplant device in Real-World use

NCT ID NCT06513091

Knowledge-focused Sponsor: TransMedics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This registry will collect short- and long-term outcome data from up to 10,000 lung transplant recipients whose donor lungs were preserved using the OCS Lung device. The goal is to see how well the device performs in everyday medical practice after FDA approval. Researchers will track one-year patient and graft survival rates.

What this could mean

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

What this could lead to
If successful, this registry will provide real-world data on how well the OCS Lung device works for preserving donor lungs, potentially improving transplant outcomes.
What could go wrong
This is an observational registry, not a controlled trial. It cannot prove cause and effect, and results may be influenced by factors other than the device.

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 10,000 people

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

Started

Jan 2025

Expected to finish

Nov 2039

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

The US National TOP Registry will enroll all lung transplant recipients who are transplanted with OCS-perfused donor lung(s) in the Registry, as well as patients transplanted using other preservation modalities for benchmarking clinical outcomes.

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.

All lung transplant recipients

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As listed by the trial registrant

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

Lung transplant

How to take part

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

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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 College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Baylor Scott & White Research Institute

    RECRUITING

    Dallas, Texas, 75246, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • St. Joseph's Hospital & Medical Center

    RECRUITING

    Phoenix, Arizona, 85013, United States

  • Stanford University School of Medicine

    RECRUITING

    Stanford, California, 94305, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

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