A Bionic Breast Project Using Neuroprosthesis to Reduce Chronic Pain After Mastectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Requires adjuvant chemotherapy
Single stage mastectomy and reconstruction procedure
Clinical evidence of bilateral breast cancer
Clinical evidence of lymph node involvement
Trial design
Treatments tested in this trial
- Bionic Breast implant
Treatment groups
8 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Chicago
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov