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Wearable Ultrasound Patch for Breast Imaging

{ "Wearable Ultrasound Patch for Breast Imaging", "This study is testing a new device called the Wearable Ultrasound Patch. This patch is a flexible, skin-adherent device that provides real-time, 3D images of the breast. Researchers want to see how well it can find breast lesions (abnormal areas) compared to standard ultrasound. You might be able to join if you are a woman between 18 and 85 years old, and have had or will have a conventional breast ultrasound soon. The study aims to enroll 50 participants. The success of the study will be measured by how accurately the patch detects breast lesions.", "design": "This is an interventional study planning to enroll 50 participants. It compares the Wearable Ultrasound Patch to conventional ultrasound.", "commitments": "You will have breast imaging performed with the Wearable Ultrasound Patch, which is applied directly to your breast and secured with a sports bra. The imaging session will take less than 15 minutes.", "compensation": "Not stated in the trial record.", "follow_up": "Your imaging results will be assessed within one week after the initial imaging.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07186491

Wearable Ultrasound Patch for Breast Imaging

Not Yet Recruiting
NAAges 18–85InterventionalDiagnostic
Massachusetts General Hospital
~50 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Wearable Ultrasound Patch

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity and Specificity of the Wearable Ultrasound Patch for Detecting Breast Lesions
Measured over From enrollment to 1 week after initial imaging

Conditions

Breast Cancer
Breast Abnormalities
Breast Lesion
Breast Asymmetry

Explore related trials

Breast CarcinomaCongenital anomaly of breast

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Tolga Ozmen, M.D. · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Tolga Ozmen, M.D.
[email protected]
617-643-4398
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Sensitivity and Specificity of the Wearable Ultrasound Patch for Detecting Breast LesionsFrom enrollment to 1 week after initial imaging

    The primary outcome will assess the diagnostic accuracy of the conformable US-patch device by comparing its breast lesion detection results to conventional handheld ultrasound (reference standard). Sensitivity and specificity will be calculated per lesion using true positive, false positive, true negative, and false negative determinations based on radiologist interpretation. This metric will serve as the main assessment of the device's performance in detecting breast anomalies across a range of breast shapes, sizes, and tissue densities.