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

NCT06382272 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-04-27

No results posted yet for this study

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

Interventions

DEVICE

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Chicago

    lead OTHER

Principal Investigators

  • Stacy Lindau · University of Chicago

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-14
Primary Completion
2028-01-31
Completion
2028-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06382272 on ClinicalTrials.gov