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Wearable Ultrasound Patch for Breast Imaging
Sponsor: Massachusetts General Hospital
Summary
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.
Official title: Exploring the Application of a Wearable Ultrasound (US) Patch Device for Breast Imaging
Key Details
Gender
FEMALE
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-04-01
Completion Date
2027-03
Last Updated
2026-03-06
Healthy Volunteers
Yes
Interventions
Wearable Ultrasound Patch
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.
Locations (1)
Massachusetts General Hospital
Boston, Massachusetts, United States