RecruitingNCT07220863

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


Sponsor

Feminai

Enrollment

300 participants

Start Date

Oct 5, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 25 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new AI-assisted tool called Feminai that maps breast tissue to detect suspicious lesions. It aims to evaluate whether this technology can help find breast abnormalities in women who are either going for routine screening or already scheduled for a biopsy. **You may be eligible if...** - You are a woman between 25 and 75 years old - Group 1: You are coming in for routine mammogram screening and your last mammogram was normal or benign (BIRADS 1 or 2) - Group 2: You have a mammogram showing a suspicious finding (BIRADS 4 or 5) and are scheduled for a biopsy **You may NOT be eligible if...** - You are currently being treated for breast cancer - You are pregnant or breastfeeding - You have any implanted metal in your body - You have a condition that prevents you from following study procedures safely Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Solis Mammography Frisco at Stonebriar

Frisco, Texas, United States

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NCT07220863


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