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

NCT ID: NCT06382272

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-14
• Study Completion Date: 2028-01-31

Brief Summary

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.

Conditions

Mastectomy; Breast; Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mastectomy/Reconstruction

Standard treatment our intervention/arm is just the implanting of the device.

Group Type: EXPERIMENTAL

Bionic Breast implant

Intervention Type: DEVICE

A small medical device will be temporarily implanted in one of the breasts at the time of the mastectomy. This device is capable of sending very small electrical currents to the nerves that can deliver sensory stimulation in response to touch and pressure applied to the breast

Interventions

Bionic Breast implant

A small medical device will be temporarily implanted in one of the breasts at the time of the mastectomy. This device is capable of sending very small electrical currents to the nerves that can deliver sensory stimulation in response to touch and pressure applied to the breast

Intervention Type: DEVICE

Eligibility Criteria

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 T1 (<2 cm), 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 breast radiation
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stacy Lindau

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Trials Intake

Role: CONTACT

cancerclinicaltrials@bsd.uchicago.edu

18557028222

Facility Contacts

Clinical Trials Intake

Role: primary

cancerclinicaltrials@bsd.uchicago.edu

855-702-8222

Bionic Breast Team

Role: backup

(773) 873-2011

Other Identifiers

IRB23-2027

Identifier Type: -

Identifier Source: org_study_id