Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai

Part of paid clinical trials in Frisco, Texas.

Sponsor
Feminai
Study ID
NCT07220863
Status
Recruiting
Apply to this trial

Conditions

  • Breast Cancer Awareness

Eligibility Criteria

Sex
FEMALE
Age
25 Years - 75 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Oct 5, 2025
Status verified
Oct 2025
Primary completion
Jun 5, 2026
Completion
Sep 5, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: breast cancer screening
    Women between the ages 25-75 undergoing breast cancer screening

Primary Outcome Measure

Sensitivity and NPV [ Time Frame: From enrollment to the time the the ground truth is available followed for up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Solis Mammography Frisco at StonebriarFriscoTexas75034
Jennifer Pantleo, RN BSN BBA CBCN
[email protected]
214-872-4484

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Solis Mammography Frisco at Stonebriar· Frisco, TX

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