Home breast mapping with the Feminai adhesive patch to detect suspicious lesions
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
Run by Feminai · NCT07220863 · Data updated 2026-11-12
This project will test whether an at-home Feminai adhesive patch that measures skin temperature and electrical impedance can help detect suspicious breast lesions in women ages 25–75 undergoing screening mammography or biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 25 Years to 75 Years |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | Feminai Industry-sponsored |
| Locations | 1 site (Frisco, Texas) |
| Status | Recruiting |
| Started | October 5, 2025 |
| Main results expected | June 5, 2026 |
| Study ends | September 5, 2026 |
| Registry record updated | October 24, 2025 |
| Trial ID | NCT07220863 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 25–75 who are presenting for routine screening mammography (BI-RADS 1–2) or who are scheduled for biopsy after a higher-concern mammogram (BI-RADS 4–5), and who are able to provide consent and comply with study procedures, are the intended participants.
✕Probably not a fit
Women currently undergoing treatment for breast cancer, who are pregnant or breastfeeding, who have breast implants or recent breast surgery, metal implants, or very large cup sizes are unlikely to be eligible or to receive benefit from this device.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study will enroll up to 300 women aged 25–75, split between routine screening (BI-RADS 1–2) and those scheduled for biopsy after concerning mammograms (BI-RADS 4–5). Trained staff will apply the Feminai adhesive patch in a private room during a single study visit to record skin-surface temperature and electrical impedance and generate a breast map. Feminai results will be compared with contemporaneous mammography and, when available, biopsy results to estimate sensitivity and negative predictive value. The device is investigational and intended to support, not replace, standard diagnostic tests.
Why it matters
Potential benefit: If successful, Feminai could offer a noninvasive at-home mapping tool that helps flag suspicious breast lesions earlier or reduce unnecessary follow-up procedures.
How similar studies have gone: Previous small studies of thermal and electrical-impedance wearable approaches have produced mixed results, so this approach is promising but not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: General: 1. Females aged 25-75 years. 2. Able to comply with study procedures and follow-up requirements. 3. Willing and able to provide informed consent. Additional for Group 1 (up to N=150): 1. Presenting for routine mammography/tomosynthesis breast cancer screening according to national/regional guidelines. 2. Most recent mammography result - BIRADS 1 or 2 Additional for Group 2 (up to N=150): 1\. Presenting for biopsy following BIRADS 4-5 mammogram Exclusion Criteria: 1. History of current treatment for breast cancer. 2. Pregnancy or lactation. 3. Presence of any implanted metal. 4. Any condition that, in the opinion of the investigator, may interfere with the participant's ability to comply with study requirements or may pose a risk to the participant. 5. Has breast enhancements (e.g. implants or injections) 6. Subjects who have undergone surgery (e.g. lumpectomy or mastectomy) in the last year at the time of study enrollment 7. No subject will be allowed to enroll in this trial more than once. 8. Cup size larger than E in US-based sizing charts.
Where it's running
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Solis Mammography Frisco at Stonebriar
Frisco, Texas, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.