MastectomyNCT06382272
A Bionic Breast Project Using Neuroprosthesis to Reduce Chronic Pain After Mastectomy
A study testing Bionic Breast implant in people with Mastectomy and Breast, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastectomy, Breast, Chronic Pain
- What is being tested?
- Bionic Breast implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2025to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Clinical Trials Intake, 18557028222, cancerclinicaltrials@bsd.uchicago.edu
Bionic Breast Team, (773) 873-2011
About this study
Official title: Bionic Breast Project: A Neuroprosthesis to Restore Touch Sensation and Reduce Chronic Pain After Mastectomy
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
- Being tested
- Bionic Breast implant
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bionic Breast implantDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Mastectomy/Reconstruction | Experimental | Standard treatment our intervention/arm is just the implanting of the device. Receives: Device: Bionic Breast implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychophysical tasks to assess stimulation-elicited sensation
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.
Measured: 7 months after mastectomy+implantation and removal of device
Secondary outcomes (5)
Maximum stimulation level
To determine the maximum range of stimulation that elicits comfortable sensation.
Measured: 7 months after mastectomy+implantation and removal of device
Amplitude discrimination task
The purpose of this task is to determine the amount by which PA needs to be changed to evoke a reliably distinguishable percept for each C-FINE contact.
Measured: 7 months after mastectomy+implantation and removal of device
Frequency discrimination task
The purpose of this task is to determine the amount by which pulse frequency (PF) needs to change to evoke a reliably distinguishable percept for each C-FINE contact.
Measured: 7 months after mastectomy+implantation and removal of device
Magnitude estimation
The purpose of this task is to (further) characterize the relationship between PA/PF and sensory magnitude.
Measured: 7 months after mastectomy+implantation and removal of device
Projected field mapping
The purpose of this task is to map the location of percepts evoked by stimulation through each C-FINE contact.
Measured: 7 months after mastectomy+implantation and removal of device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start14 May 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stacy Lindau, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382272
- Sponsor's protocol ID
- IRB23-2027
- Other IDs
- 5R01CA281301
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bionic Breast Project: A Neuroprosthesis to Restore Touch Sensation and Reduce Chronic Pain After Mastectomy
- ClinicalTrials.gov ID
- NCT06382272
- Acronym / sponsor ID
- IRB23-2027
- Conditions
- Mastectomy, Breast, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 May 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mastectomy/Reconstruction | Experimental | Device: Bionic Breast implantStandard treatment our intervention/arm is just the implanting of the device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bionic Breast implantA 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 | Device | Mastectomy/Reconstruction |
Primary outcome
Psychophysical tasks to assess stimulation-elicited sensation
Time frame: 7 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.
5 secondary outcomes
Maximum stimulation level
Time frame: 7 months after mastectomy+implantation and removal of device
Amplitude discrimination task
Time frame: 7 months after mastectomy+implantation and removal of device
Frequency discrimination task
Time frame: 7 months after mastectomy+implantation and removal of device
Magnitude estimation
Time frame: 7 months after mastectomy+implantation and removal of device
Projected field mapping
Time frame: 7 months after mastectomy+implantation and removal of device
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stacy Lindau principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bionic Breast implant in people with Mastectomy and Breast, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Intake (18557028222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychophysical tasks to assess stimulation-elicited sensation (time frame: 7 months after mastectomy+implantation and removal of device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.