[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609921":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":12,"responsibleParty":33,"collaborators":10,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":10,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":10,"studyType":48,"phases":10,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":15,"whyStopped":10,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},{"fullName":5,"class":6},"Feminai","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"breast cancer screening",null,"Women between the ages 25-75 undergoing breast cancer screening",[13],{"facility":14,"status":15,"city":16,"state":17,"zip":18,"country":19,"countryCode":20,"cosmosGeoPoint":21,"geoPoint":26,"contacts":27},"Solis Mammography Frisco at Stonebriar","RECRUITING","Frisco","Texas","75034","United States","US",{"type":22,"coordinates":23},"Point",[24,25],-96.82361,33.15067,{"lat":25,"lon":24},[28],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Jennifer Pantleo, RN BSN BBA CBCN","CONTACT","214-872-4484","Jennifer.Pantleo@solismammo.com",{"type":34,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100609921","breast-mapping-and-detection-of-suspicious-breast-lesions-using-feminai-100609921",false,"NCT07220863","Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai","Evaluation of the Safety and Efficacy of a Wearable Device Based on Thermometry and Impedance Technology for Breast Mapping and Detecting Suspicious Breast Lesions Using Feminai 1.0","Inclusion Criteria:\n\nGeneral:\n\n1. Females aged 25-75 years.\n2. Able to comply with study procedures and follow-up requirements.\n3. Willing and able to provide informed consent.\n\nAdditional for Group 1 (up to N=150):\n\n1. Presenting for routine mammography\u002Ftomosynthesis breast cancer screening according to national\u002Fregional guidelines.\n2. Most recent mammography result - BIRADS 1 or 2\n\nAdditional for Group 2 (up to N=150):\n\n1\\. Presenting for biopsy following BIRADS 4-5 mammogram\n\nExclusion Criteria:\n\n1. History of current treatment for breast cancer.\n2. Pregnancy or lactation.\n3. Presence of any implanted metal.\n4. Any condition that, in the opinion of the investigator, may interfere with the participant's ability to comply with study requirements or may pose a risk to the participant.\n5. Has breast enhancements (e.g. implants or injections)\n6. Subjects who have undergone surgery (e.g. lumpectomy or mastectomy) in the last year at the time of study enrollment\n7. No subject will be allowed to enroll in this trial more than once.\n8. Cup size larger than E in US-based sizing charts.","FEMALE","25 Years","75 Years",{"count":46,"type":47},300,"ESTIMATED","OBSERVATIONAL","Prospective observational study evaluating the safety and accuracy of Feminai 1.0, an at-home adhesive patch that measures skin temperature and electrical impedance to map each breast. Up to 300 women (ages 25-75) undergoing screening will have one study visit; Feminai results will be compared with mammography and, when available, biopsy to assess sensitivity and negative predictive value. Feminai is investigational, intended to support clinical decision-making, and does not replace standard diagnostic tests.",[51],"Breast Cancer Awareness",[53,54,55,56,57,58],"Breast lesions","Breast mapping","Home breast examination","Wearable patch","Thermometry","Bioimpedance","2025-10-22",{"date":61,"type":62},"2025-10-24","ACTUAL",{"date":64,"type":62},"2025-10-05",{"date":66,"type":47},"2026-09-05",{"name":5,"class":6},1]