Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Awareness | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- breast cancer screening
- description
- Women between the ages 25-75 undergoing breast cancer screening
Primary outcomes (2)
- measure
- Sensitivity and NPV
- timeFrame
- From enrollment to the time the the ground truth is available followed for up to 6 months
- measure
- Sensitivity and NPV
- timeFrame
- From enrollment to the time that the mammography and biopsy results (if applicable) are available followed for up to 6 months.
- description
- The co-primary endpoints will be defined on a per patient basis as sensitivity and NPV. The endpoints will be based on the binary outcomes produced for each breast side (right and left). For side-level analysis, the definitions of True Positive (TP), False Positive (FP), True Negative (TN), and False Negative (FN) are as follows: TP side: Side is Ground Truth (GT) positive and Flagged by device FP side: Side is GT negative and Flagged by device FN side: Side is GT positive and Not Flagged by device TN side: Side is GT negative and Not Flagged by device For subject-level analysis, the definitions of TP, FP, TN, and FN are based on side-level classification, as follows: TP subject: A subject has only one GT positive side and this side is Flagged by the device. Or, a subject has 2 GT positive sides and at least one side is Flagged by device. FN subject: A subject has one or two GT positive sides and none of these sides is Flagged by the device FP subject: A subject has both sides GT
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available