Mastectomy study: Bionic Breast implant
Official title A Bionic Breast Project Using Neuroprosthesis to Reduce Chronic Pain After Mastectomy
ClinicalTrials.gov ID: NCT06382272
What this study is testing
- What it's testing
- The study wants to find out if neural stimulation can bring back touch sensation in the breast and to collect safety and feasibility information.
- Who it's for
- People who have had a mastectomy and are experiencing chronic breast pain.
- What's involved
- Participants will have a neuroprosthetic placed that delivers neural stimulation, and will attend follow‑up visits and tests to check sensation and safety.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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
You likely can't join if
- 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)
See the full eligibility 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.
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.