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New registry aims to boost lung transplants by reconditioning donor lungs

NCT ID NCT05101460

Disease control Sponsor: XVIVO Perfusion 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This registry follows 315 people who received a lung transplant after the donor lung was treated with the XVIVO Perfusion System, a device that keeps lungs warm and oxygenated outside the body. Researchers are tracking survival and lung function for up to 5 years to see how well these lungs perform long-term. The goal is to gather real-world data on safety and effectiveness.

What this could mean

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

Active substance
XVIVO Perfusion System with STEEN Solution
What this could lead to
If successful, this could confirm that EVLP helps more donor lungs become usable for transplant, potentially increasing the number of lung transplants available.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove EVLP is better than standard care. Results may not apply to all transplant centers.

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 315 people

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

Started

Oct 2019

Expected to finish

Apr 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

This is an "All Comers Registry" hence, no specific investigator sites. All patients receiving EVLP lungs treated with XPS™ will be included in the registry without eligibility criteria or pre-selection. Since the registry collects only standard-of-care data and requires no additional procedures or risks to the subject, a waiver of consent is appropriate

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.

This is an "All Comers Registry" hence will include all patients receiving EVLP lungs.

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As listed by the trial registrant

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

Lung transplant

Contacts and locations

Locations

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

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