Status:
RECRUITING
Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai
Lead Sponsor:
Feminai
Conditions:
Breast Cancer Awareness
Eligibility:
FEMALE
25-75 years
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...
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 whet...
Eligibility Criteria
Inclusion
- General:
- Females aged 25-75 years.
- Able to comply with study procedures and follow-up requirements.
- Willing and able to provide informed consent.
- Additional for Group 1 (up to N=150):
- Presenting for routine mammography/tomosynthesis breast cancer screening according to national/regional guidelines.
- 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
- History of current treatment for breast cancer.
- Pregnancy or lactation.
- Presence of any implanted metal.
- 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.
- Has breast enhancements (e.g. implants or injections)
- Subjects who have undergone surgery (e.g. lumpectomy or mastectomy) in the last year at the time of study enrollment
- No subject will be allowed to enroll in this trial more than once.
- Cup size larger than E in US-based sizing charts.
Key Trial Info
Start Date :
October 5 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 5 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07220863
Start Date
October 5 2025
End Date
September 5 2026
Last Update
October 24 2025
Active Locations (1)
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1
Solis Mammography Frisco at Stonebriar
Frisco, Texas, United States, 75034