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Could a simple heat device save nipples after top surgery?

NCT ID NCT06502353

Symptom relief Sponsor: Plexaa Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests a heat preconditioning device (BLOOM43) in 15 transgender or non-binary people undergoing gender affirming mastectomy. Participants use the device on their right breast the night before surgery. The study focuses on how usable and acceptable the device is, and also tracks nipple healing and complications.

What this could mean

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

Active substance
Plexaa preconditioning device (BLOOM43) - a heat preconditioning device
What this could lead to
If successful, this device could reduce the risk of nipple necrosis or graft loss after gender affirming mastectomy, improving surgical outcomes.
What could go wrong
This is a very small pilot study with only 15 participants, so results may not apply widely. The device is experimental and its effectiveness is not yet proven.

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 15 people

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

Started

Aug 2025

Expected to finish

Jun 2026

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.

Ages

18 years and older

Sex

Female participants only

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: * All transgender or non-binary patients over the age of 18 years (no maximum age limit) * Patients undergoing peri-areolar mastectomy or double incision mastectomy with a free nipple graft for gender affirmation Exclusion Criteria: * Patients undergoing surgery for breast cancer * Delayed (two-stage) breast reconstruction patients * Patients undergoing simple mastectomy or wide local excision of a breast tumour * Presence of open breast skin wounds, or infected or inflamed breast skin * Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device

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As listed by the trial registrant

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

Nipple graft loss Nipple necrosis

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

  • Division of Plastic & Reconstructive Surgery, Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States