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.
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Sensitivity and NPV
Timeframe: From enrollment to the time the the ground truth is available followed for up to 6 months
Sensitivity and NPV
Timeframe: From enrollment to the time that the mammography and biopsy results (if applicable) are available followed for up to 6 months.