NCT07220863 Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai
| NCT ID | NCT07220863 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Feminai |
| Condition | Breast Cancer Awareness |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-10-05 |
| Primary Completion | 2026-06-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-10-05 with a primary completion date of 2026-06-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Frequently Asked Questions
Who can join the NCT07220863 clinical trial?
This trial is open to female participants only, aged 25 Years or older, up to 75 Years, studying Breast Cancer Awareness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07220863 currently recruiting?
Yes, NCT07220863 is actively recruiting participants. Visit ClinicalTrials.gov or contact Feminai to inquire about joining.
Where is the NCT07220863 trial being conducted?
This trial is being conducted at Frisco, United States.
Who is sponsoring the NCT07220863 clinical trial?
NCT07220863 is sponsored by Feminai. The trial plans to enroll 300 participants.
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