Wearable Ultrasound Patch for Breast Imaging (NCT07186491) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Wearable Ultrasound Patch for Breast Imaging
United States50 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity and Specificity of the Wearable Ultrasound Patch for Detecting Breast Lesions
Timeframe: From enrollment to 1 week after initial imaging