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Wearable Ultrasound Patch for Breast Imaging
Wearable Ultrasound Patch for Breast Imaging

NCT07186491

Not Yet RecruitingNA

Sponsor: Massachusetts General Hospital

Conditions: Breast Cancer, Breast Abnormalities, Breast Lesion, Breast Asymmetry

Interventions: Wearable Ultrasound Patch

Countries: United States

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 overview

Sex: FEMALE

Age: 18 Years to 85 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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)
Locations (1)
  • Boston, Massachusetts, United States