Clinical trial · Interventional
Wearable Ultrasound Patch for Breast Imaging
Exploring the Application of a Wearable Ultrasound (US) Patch Device for Breast Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Abnormalities | — | UNRESOLVED | — |
| Breast Asymmetry | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Lesion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Wearable Ultrasound Patch | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast Imaging with Wearable Ultrasound Device
- description
- Participants in this arm will undergo breast imaging using the wearable ultrasound (US) patch device. The patch is a flexible, skin-adherent transducer array designed to provide whole-breast 3D ultrasound imaging. It will be applied directly to the breast with coupling gel and secured with a sports bra to maintain contact. Imaging will be completed in less than 15 minutes, and results will be compared with conventional ultrasound, which serves as the reference standard.
- interventionNames
- Device: Wearable Ultrasound Patch
Primary outcomes (1)
- measure
- Sensitivity and Specificity of the Wearable Ultrasound Patch for Detecting Breast Lesions
- timeFrame
- From enrollment to 1 week after initial imaging
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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)
References
Publications (2)
- BACKGROUNDZhou S, Park G, Longardner K, Lin M, Qi B, Yang X, Gao X, Huang H, Chen X, Bian Y, Hu H, Wu RS, Yue W, Li M, Lu C, Wang R, Qin S, Tasali E, Karrison T, Thomas I, Smarr B, Kistler EB, Khiami BA, Litvan I, Xu S. Clinical validation of a wearable ultrasound sensor of blood pressure. Nat Biomed Eng. 2025 Jun;9(6):865-881. doi: 10.1038/s41551-024-01279-3. Epub 2024 Nov 20. PMID 39567702
- BACKGROUNDDu W, Zhang L, Suh E, Lin D, Marcus C, Ozkan L, Ahuja A, Fernandez S, Shuvo II, Sadat D, Liu W, Li F, Chandrakasan AP, Ozmen T, Dagdeviren C. Conformable ultrasound breast patch for deep tissue scanning and imaging. Sci Adv. 2023 Jul 28;9(30):eadh5325. doi: 10.1126/sciadv.adh5325. Epub 2023 Jul 28. PMID 37506210