Bionic breast implant to restore touch and reduce chronic pain after mastectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants will receive a neuroprosthetic bionic breast implant placed during reconstruction after bilateral mastectomy and will have targeted neural stimulation intended to restore touch sensation. The study will collect safety, sensation, pain, and acceptability data during the implant period and through planned removal of the tissue expander 12–20 weeks after implantation. Outcomes will include measures of touch perception, changes in chronic post-mastectomy pain, and participant-reported experience with the device. Data are intended to inform future feasibility, safety, and efficacy trials of this approach.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Chicago Medicine Comprehensive Cancer Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Stacy Lindau — University of Chicago
• Study coordinator: Clinical Trials Intake
• Email: cancerclinicaltrials@bsd.uchicago.edu
• Phone: 18557028222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.