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Bionic Breast Project for Chronic Pain After Mastectomy

This study is exploring if a Bionic Breast implant can help restore touch sensation after a mastectomy. This small device is temporarily placed in one breast during your mastectomy and sends tiny electrical currents to nerves, allowing you to feel touch and pressure. Researchers want to see if this can reduce chronic pain. You might be able to join if you are 18 or older, are having a bilateral mastectomy (removal of both breasts) with a two-stage reconstruction at UCM, and have early-stage breast cancer or a high risk of breast cancer. The study aims to understand if this approach is safe and effective. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 8 women. The phase of the study is not specified.
What's involved
A small medical device will be temporarily implanted in one breast during your mastectomy. Your sensation will be assessed 7 months after the mastectomy and device removal.
Compensation
Not stated in the trial record.
Follow-up
Your sensation will be assessed 7 months after the mastectomy and device removal.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06382272

A Bionic Breast Project Using Neuroprosthesis to Reduce Chronic Pain After Mastectomy

Recruiting
NAAges 18+InterventionalSupportive care
University of Chicago
~8 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:Bionic Breast implant

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Psychophysical tasks to assess stimulation-elicited sensation
Measured over 7 months after mastectomy+implantation and removal of device

Conditions

Mastectomy
Breast
Chronic Pain

Explore related trials

Breast Cancer Risk ReductionBreast Carcinoma

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Stacy Lindau · PRINCIPAL_INVESTIGATOR · University of Chicago

Who to contact

Clinical Trials Intake
[email protected]
18557028222
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Psychophysical tasks to assess stimulation-elicited sensation7 months after mastectomy+implantation and removal of device

    The purpose of the detection task is to determine the minimum pulse amplitude (PA) required to elicit a detectable percept for each C-FINE contact.