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

RecruitingNot applicableNCT06382272
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

This trial seeks to establish whether or not touch sensation can be restored to the breast via neural stimulation. Data will also be obtained to inform future feasibility (including safety), efficacy, and acceptability trials.

Study details

Official title
Bionic Breast Project: A Neuroprosthesis to Restore Touch Sensation and Reduce Chronic Pain After Mastectomy
Conditions
Interventions
  • Device: Bionic Breast implant
Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)
Start date
2025-05-14
Primary completion
2028-01-31
Sex
Female
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06382272