Wearable Ultrasound Patch for Breast Imaging

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07186491
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Wearable Ultrasound Patch — DEVICE
    The Wearable Ultrasound Patch is a non-invasive imaging device designed to provide real-time breast imaging (3D) through a flexible, skin-adherent US transducer array. The patch conforms to the natural shape of the breast and allows for continuous and comfortable imaging, reducing patient discomfort and improving diagnostic efficiency. It is intended for use as an adjunct imaging tool for breast health assessment, enabling early detection and follow up of lesions in diverse breast morphologies. Patients will use a newly developed software application named "myFUS" to properly position the US probe on their body. The software application will prompt patients through all the required steps to complete the screening. The first imaging session will be performed by the study personnel with the help of the myFUS application.

Study Details

The goal of this clinical trial is to learn if a wearable ultrasound (US) patch can provide reliable whole-breast imaging and accurately detect breast lesions in patients undergoing breast health evaluation. The main questions it aims to answer are: * How well does the US-patch detect breast lesions in breasts of different shapes, sizes, and tissue densities? * Are there any side effects or discomfort from using the US-patch? Researchers will compare results from the wearable US-patch to conventional ultrasound to see if the patch provides specific and sensitive findings. Participants will: * Have breast imaging performed with the wearable US-patch, which is applied directly to the breast and secured with a sports bra. * Use a guiding software application that helps correctly position the patch. * Complete the imaging session in less than 15 minutes, performed by study personnel.

Key Dates

Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Breast Imaging with Wearable Ultrasound Device
    Participants in this arm will undergo breast imaging using the wearable ultrasound (US) patch device. The patch is a flexible, skin-adherent transducer array designed to provide whole-breast 3D ultrasound imaging. It will be applied directly to the breast with coupling gel and secured with a sports bra to maintain contact. Imaging will be completed in less than 15 minutes, and results will be compared with conventional ultrasound, which serves as the reference standard.

Primary Outcome Measure

Sensitivity and Specificity of the Wearable Ultrasound Patch for Detecting Breast Lesions [ Time Frame: From enrollment to 1 week after initial imaging ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Tolga Ozmen, M.D.
[email protected]
617-643-4398

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Massachusetts General Hospital· Boston, MA

Related Studies