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Mini cryoprobe may sharpen lung rejection detection in transplant patients

NCT ID NCT06824402

Knowledge-focused Sponsor: Mayo Clinic 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two biopsy methods—a standard forceps and a new miniature cryoprobe—to see which better detects rejection in lung transplant recipients. About 100 participants will be randomly assigned to one method during their scheduled biopsy. The goal is to find which technique provides higher quality tissue samples for pathologists to confidently diagnose rejection.

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 could lead to a more accurate and efficient way to diagnose lung transplant rejection, helping doctors make better treatment decisions.
What could go wrong
This is an early feasibility study with only 100 participants, so results may not apply to all patients. The cryoprobe is new and could have unknown risks or not improve diagnosis as hoped.

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

About 100 people

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

Started

Feb 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 99 years

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 * Male and female lung transplant recipients age \>18 at the time of informed consent * Patients clinically meet indication for post-transplant lung biopsy or planned routine surveillance and have been scheduled for bronchoscopy with transbronchial biopsy. * Be willing and able to sign the informed consent. Exclusion Criteria * Patients with known bleeding diathesis * Platelet count \<50,000 per μL within 14 days of the biopsy procedure * Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable) * Inability or unwillingness to give informed consent or study procedures * Pregnant or nursing females, or females who intend to become pregnant * Females of child-bearing potential who decline a pregnancy test prior to enrollment * If an investigator does not feel that this study is in the subject's best interest or would be a good fit for the study. * International Normalized Ratio (INR) \>1.5 * Do Not Resuscitate (DNR) status * Do Not Intubate (DNI) status * Single lung transplant recipients

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Conditions

The condition(s) this trial relates to.

transplant rejection

As listed by the trial registrant

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

Lung transplant rejection

How to take part

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

  1. The places running it

    1 site. 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

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

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