Bionic breast implant aims to bring back sensation after mastectomy
NCT ID NCT06382272
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
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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
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About 8 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University of Chicago Medicine Comprehensive Cancer Center
RECRUITINGChicago, Illinois, 60637, United States
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Other studies related to the condition(s) this trial covers.
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