Recruiting

Feminai 1.0

Sponsor:

Feminai

Code:

NCT07220863

Conditions

Breast Cancer Awareness

Eligibility Criteria

Sex: Female

Age: 25 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Breast Cancer Awareness

Study ID

NCT07220863

Start date

Oct 5, 2025

Status verified date

Oct, 2025

Completion date

Sep 5, 2026

Anticipated

Primary completion date

Jun 5, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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 ]
  • Sensitivity and NPV [ Time Frame: From enrollment to the time that the mammography and biopsy results (if applicable) are available followed for up to 6 months. ]

Central Contacts and Locations

Locations

Solis Mammography Frisco at Stonebriar

Recruiting

Frisco, Texas, United States, 75034

Contacts

Jennifer Pantleo, RN BSN BBA CBCN

214-872-4484Jennifer.Pantleo@solismammo.com

More Information

Sponsor

Feminai

Last update posted

Oct 24, 2025

Last verified

Oct, 2025

Keywords

  • Breast lesions
  • Breast mapping
  • Home breast examination
  • Wearable patch
  • Thermometry
  • Bioimpedance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Feminai on 2025-10-24.