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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
Who can join
Ages 25 to 75 · Women
Full eligibility criteria
Inclusion Criteria: General: 1. Females aged 25-75 years. 2. Able to comply with study procedures and follow-up requirements. 3. Willing and able to provide informed consent. Additional for Group 1 (up to N=150): 1. Presenting for routine mammography/tomosynthesis breast cancer screening according to national/regional guidelines. 2. Most recent mammography result - BIRADS 1 or 2 Additional for Group 2 (up to N=150): 1\. Presenting for biopsy following BIRADS 4-5 mammogram Exclusion Criteria: 1. History of current treatment for breast cancer. 2. Pregnancy or lactation. 3. Presence of any implanted metal. 4. 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. 5. Has breast enhancements (e.g. implants or injections) 6. Subjects who have undergone surgery (e.g. lumpectomy or mastectomy) in the last year at the time of study enrollment 7. No subject will be allowed to enroll in this trial more than once. 8. Cup size larger than E in US-based sizing charts.
About the study
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.
Sponsor: Feminai · Participants: 300 · Started: Oct 5, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT07220863
Locations in the U.S.
| Texas | Solis Mammography Frisco at Stonebriar, Frisco |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.