[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607279":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":45,"collaborators":48,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":74,"overallStatus":78,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Breast Imaging with Wearable Ultrasound Device","EXPERIMENTAL","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.",[13],"Device: Wearable Ultrasound Patch",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Wearable Ultrasound Patch","The Wearable Ultrasound Patch is a non-invasive imaging device designed to provide real-time breast imaging (3D) through a flexible, skin-adherent US transducer array. The patch conforms to the natural shape of the breast and allows for continuous and comfortable imaging, reducing patient discomfort and improving diagnostic efficiency. It is intended for use as an adjunct imaging tool for breast health assessment, enabling early detection and follow up of lesions in diverse breast morphologies. Patients will use a newly developed software application named \"myFUS\" to properly position the US probe on their body. The software application will prompt patients through all the required steps to complete the screening. The first imaging session will be performed by the study personnel with the help of the myFUS application.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Tolga Ozmen, M.D.","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","617-643-4398","tozmen@mgh.harvard.edu",[31],{"facility":5,"status":20,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Boston","Massachusetts","02114","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-71.05977,42.35843,{"lat":41,"lon":40},[44],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},{"type":24,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Tolga Ozmen, MD","Breast Surgery, Surgical Oncology",[49],{"name":50,"class":6},"Massachusetts Institute of Technology","100607279","wearable-ultrasound-patch-for-breast-imaging-100607279",false,"NCT07186491","Wearable Ultrasound Patch for Breast Imaging","Exploring the Application of a Wearable Ultrasound (US) Patch Device for Breast Imaging","Inclusion Criteria:\n\n* 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.\n* Patients with a history of breast cancer or prior breast surgery can also be enrolled\n* Female gender\n* Ages between 18 and 85 years old\n* Being able to understand, communicate, give valid consent to the study, and be understood by researchers\n\nExclusion Criteria:\n\n* Having significant health problems (such as chronic or acute cardiovascular diseases, skin diseases) physical and\u002For behavioral health disabilities limiting participants' ability to follow directions and complete research related activities.\n* Being pregnant\n* Not having intact, healthy breast skin (having open scars or wounds around the location of the breast)",true,"FEMALE","18 Years","85 Years",{"count":63,"type":64},50,"ESTIMATED","INTERVENTIONAL",[67],"NA","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:\n\n* How well does the US-patch detect breast lesions in breasts of different shapes, sizes, and tissue densities?\n* Are there any side effects or discomfort from using the US-patch?\n\nResearchers will compare results from the wearable US-patch to conventional ultrasound to see if the patch provides specific and sensitive findings.\n\nParticipants will:\n\n* Have breast imaging performed with the wearable US-patch, which is applied directly to the breast and secured with a sports bra.\n* Use a guiding software application that helps correctly position the patch.\n* Complete the imaging session in less than 15 minutes, performed by study personnel.",[70,71,72,73],"Breast Cancer","Breast Abnormalities","Breast Lesion","Breast Asymmetry",[75,70,76,72,77],"Breast Imaging","Wearable Imaging","Ultrasound","NOT_YET_RECRUITING","2026-03-04",{"date":81,"type":82},"2026-03-06","ACTUAL",{"date":84,"type":64},"2026-04-01",{"date":86,"type":64},"2027-03",{"name":5,"class":6},1]