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NCT07186491
Wearable Ultrasound Patch for Breast Imaging
Conditions: Breast Cancer, Breast Abnormalities, Breast Lesion, Breast Asymmetry
Sex: Female
Ages: 18 Years – 85 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 50
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Boston Massachusetts
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.
Eligibility Criteria
Inclusion Criteria:
* Investigators will exclusively enroll patients who have undergone conventional US imaging for their breasts within the past month or are scheduled to undergo it within the upcoming month.
* Patients with a history of breast cancer or prior breast surgery can also be enrolled
* Female gender
* Ages between 18 and 85 years old
* Being able to understand, communicate, give valid consent to the study, and be understood by researchers
Exclusion Criteria:
* Having significant health problems (such as chronic or acute cardiovascular diseases, skin diseases) physical and/or behavioral health disabilities limiting participants' ability to follow directions and complete research related activities.
* Being pregnant
* Not having intact, healthy breast skin (having open scars or wounds around the location of the breast)
Source: ClinicalTrials.gov (NCT07186491). StuddyBuddy aggregates publicly available trial information.