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Wearable Ultrasound Patch for Breast Imaging

Exploring the Application of a Wearable Ultrasound (US) Patch Device for Breast Imaging

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound, Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "This study is designed to evaluate the performance, safety, and reliability of a newly developed conformable wearable ultrasound (US) patch for whole-breast imaging."
  • "The primary goal of the study is to assess the diagnostic accuracy of the US-patch device in detecting breast lesions across a variety of breast shapes, sizes, and tissue densities, using conventional handheld ultrasound as the reference standard (ground truth)."
  • "Investigators plan to enroll 50 patients over a 12-month period who are undergoing breast health evaluation and either have had or are scheduled for conventional breast ultrasound within one month."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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)

Study sites (1)

MA