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Bionic breast implant aims to bring back sensation after mastectomy

NCT ID NCT06382272

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early study tests a small device temporarily implanted in the breast during mastectomy. The device sends tiny electrical pulses to nerves to try to restore touch sensation and reduce chronic pain. Only 8 people having both breasts removed will take part, to see if the idea is feasible and safe.

What this could mean

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

Active substance
Bionic Breast implant (a small medical device that sends electrical currents to nerves in response to touch)
What this could lead to
If successful, this could point toward a way to restore feeling and reduce pain for people who have had a mastectomy, improving quality of life.
What could go wrong
This is a very early, tiny study (8 people) testing feasibility only. The device is temporary, and it may not work or may cause discomfort. Much more research is needed.

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 8 people

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

Started

May 2025

Expected to finish

Jan 2028

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 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: * 18 years of age or older * Scheduled for bilateral mastectomy with two-stage (tissue expander) reconstruction at UCM * Bilateral mastectomy for unilateral in situ or T1to T2, clinically, N0 (no lymph node involvement) breast cancer or breast cancer risk reduction due to known elevated breast cancer risk. (Note - 19-34% of women choosing mastectomy for small unilateral breast cancer elect bilateral mastectomy.)40 We will enroll from this cohort. * Agrees to have breast tissue expander removed within 12-20 weeks of implantation. * Has access to a cell phone and willing to provide the research interviewer with the cell phone number * Agrees to receive text messages from the study * Able to speak and understand English or Spanish * Able to participate in the informed consent process Exclusion criteria: * Requires adjuvant chemotherapy * Single stage mastectomy and reconstruction procedure * Clinical evidence of bilateral breast cancer * Clinical evidence of lymph node involvement * Prior history of mastectomy or other major breast surgery * Prior history of radiation to the chest area (e.g., mantle radiation for Hodgkin's disease) * Prior history of injury (e.g., trauma, surgery, burn) that the participant perceives to have had an effect on the sensation of the breast * Pregnant or intending to become pregnant during the study period * Pacemaker, defibrillator or other implanted electrical stimulation device that may be affected by the implanted electrodes * Complex regional pain syndrome or other pain syndromes or a history of a neurologic condition like multiple sclerosis, degenerative neurological disease, cognitive impairment or dementia * Uncontrolled diabetes * History of poor wound healing or chronic skin ulcerations * History of uncontrolled infection or active infection at time of consent * Expectation that MRI will be required while the devices are implanted * Inability or unwillingness to follow verbal instructions and comply with study procedures * Untreated or poorly managed physical or mental health condition that may pose additional risk according to clinical judgment of the patient's breast surgeon or surgeons * Unwillingness to undergo psychological evaluation to determine study eligibility, if requested or required by surgeons or investigators

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • University of Chicago Medicine Comprehensive Cancer Center

    RECRUITING

    Chicago, Illinois, 60637, United States

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