Mastectomy Clinical Trials

Clinical trials related to Mastectomy Procedure

Bionic Breast Project: A Neuroprosthesis to Restore Touch Sensation and Reduce Chronic Pain After Mastectomy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
University of Chicago Medicine Comprehensive Cancer Center
RECRUITING
Chicago
Contact Information
Primary
Clinical Trials Intake
cancerclinicaltrials@bsd.uchicago.edu
18557028222
Time Frame
Start Date: 2025-05-14
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 8
Treatments
Experimental: Mastectomy/Reconstruction
Standard treatment our intervention/arm is just the implanting of the device.
Related Therapeutic Areas
Sponsors
Leads: University of Chicago

This content was sourced from clinicaltrials.gov