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Could a Warm-Up device save breast reconstruction skin?

NCT ID NCT07340632

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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests a device called BLOOM43 that warms the breast skin the night before reconstructive surgery after mastectomy. The goal is to see if preconditioning reduces skin necrosis (tissue death) and improves healing. Sixty women undergoing immediate breast reconstruction will use the device at home and report their experience.

What this could mean

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

Active substance
BLOOM43 preconditioning device (heat therapy)
What this could lead to
If it works, this could reduce skin necrosis and improve recovery after breast reconstruction surgery.
What could go wrong
This is a small pilot study (60 participants) with no control group, so results may not be conclusive. The device is new and its benefits are unproven.

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 60 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 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 females over the age of 18 years (no maximum age limit) * Patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy and immediate breast reconstruction (autologous and/or implant) Exclusion Criteria: * Delayed (two-stage) breast reconstruction patients * Patients undergoing simple mastectomy or wide local excision of a breast tumour * Inflammatory breast cancer patients * Patients with ulcerated breast tumours * Patents with T4 breast cancer * 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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Conditions

The condition(s) this trial relates to.

breast cancer Necrosis

As listed by the trial registrant

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

Breast reconstruction Breast surgery Skin necrosis

How to take part

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  1. 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 ↗

  2. A doctor treating you

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