Wearable Ultrasound Patch for Breast Imaging
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-85
SponsorMassachusetts General Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Wearable Ultrasound Patch
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Massachusetts Institute of Technology
Collaborator
Source ClinicalTrials.gov