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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06382272
Status
Recruiting
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Conditions

  • Breast
  • Chronic Pain
  • Mastectomy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bionic Breast implant — DEVICE
    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 Details

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.

Key Dates

Start date
May 14, 2025
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Mastectomy/Reconstruction
    Standard treatment our intervention/arm is just the implanting of the device.

Primary Outcome Measure

Psychophysical tasks to assess stimulation-elicited sensation [ Time Frame: 7 months after mastectomy+implantation and removal of device ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637
Clinical Trials Intake
[email protected]
18557028222
Bionic Breast Team
(773) 873-2011
Stacy Lindau (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
University of Chicago Medicine Comprehensive Cancer Center· Chicago, IL

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