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
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.
Detailed description
This study will evaluate Feminai 1.0, a home breast examination kit that uses skin-surface temperature and electrical impedance measurements to create a "map" of each breast. The goal is to learn whether Feminai can help identify the presence or absence of suspicious soft-tissue lesions that may need further medical evaluation. The device is intended to support clinical decision-making and is not a stand-alone diagnostic test. Who can join: Women ages 25-75 who are undergoing breast cancer screening. Two groups will be enrolled: * About 150 women whose most recent screening mammogram was read as low concern (similar to BI-RADS 1-2). * About 150 women who are scheduled for a biopsy after a mammogram that showed higher concern (similar to BI-RADS 4-5). Key exclusions include current treatment for breast cancer, pregnancy or breastfeeding, metal implants, recent breast surgery (within 1 year), breast implants/injections, cup size larger than US size E, and any condition that would make participation unsafe or impractical. What participation involves: This is a prospective, observational study with one visit. After informed consent and eligibility confirmation, trained staff will apply the Feminai patch in a private room to collect measurements from each breast. Participants will complete a short questionnaire about their experience. Routine clinical care (such as mammography and, if planned, biopsy) will occur as usual; there is no randomization and no change to standard care. To avoid anxiety or influencing medical decisions, Feminai results will not be shared with participants or their physicians. Risks and discomforts: Expected risks are minor and temporary, similar to other adhesive skin patches: mild skin redness or irritation, itching, slight discomfort when the patch is removed, brief indentation marks, or mild dryness/sensitivity, especially with repeated applications. Serious device-related risks are not expected but will be monitored. Any device malfunctions will be recorded.
Arms & interventions
Outcome measures
Primary
Sensitivity and NPV
Time frame: From enrollment to the time the the ground truth is available followed for up to 6 months
Sensitivity and NPV
The co-primary endpoints will be defined on a per patient basis as sensitivity and NPV. The endpoints will be based on the binary outcomes produced for each breast side (right and left). For side-level analysis, the definitions of True Positive (TP), False Positive (FP), True Negative (TN), and False Negative (FN) are as follows: TP side: Side is Ground Truth (GT) positive and Flagged by device FP side: Side is GT negative and Flagged by device FN side: Side is GT positive and Not Flagged by device TN side: Side is GT negative and Not Flagged by device For subject-level analysis, the definitions of TP, FP, TN, and FN are based on side-level classification, as follows: TP subject: A subject has only one GT positive side and this side is Flagged by the device. Or, a subject has 2 GT positive sides and at least one side is Flagged by device. FN subject: A subject has one or two GT positive sides and none of these sides is Flagged by the device FP subject: A subject has both sides GT
Time frame: From enrollment to the time that the mammography and biopsy results (if applicable) are available followed for up to 6 months.
Eligibility criteria
Study locations (1)
Solis Mammography Frisco at Stonebriar
Frisco, Texas, 75034