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Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
25 Years to 75 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit
  • Procedures mentioned: Biopsies, Injections, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "Participants will complete a short questionnaire about their experience."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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.

Study sites (1)

TX