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Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai
Sponsor: Feminai
Summary
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
25 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2025-10-05
Completion Date
2026-09-05
Last Updated
2025-10-24
Healthy Volunteers
No
Conditions
Locations (1)
Solis Mammography Frisco at Stonebriar
Frisco, Texas, United States