Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai
ConditionBreast Cancer Awareness
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age25-75
SponsorFeminai
About this trial
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
Qualifiers
Females aged 25-75 years.
Able to comply with study procedures and follow-up requirements.
Willing and able to provide informed consent.
Presenting for routine mammography/tomosynthesis breast cancer screening according to national/regional guidelines.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
300 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov