N/A
Completed N=20
Tactile Breast Imaging Sensor for Tumor Malignancy Characterization
Source: ClinicalTrials.gov NCT02603211 ↗Enrolled (actual)
20
Serious AEs
—
Results posted
Jul 2019
Primary outcomePrimary: Size Error in Millimeters — 0 milimeters
Summary
The aim of this study is to see how well a tactile imaging sensor will detect for breast masses compared to traditional mammography and/or ultrasound. This device may allow a simple, convenient method to screen for breast tumors. This data will be used to check the feasibility of using the device to detect breast tumors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Size Error in Millimeters |
— | — |
| SECONDARY Malignancy Estimation Using Risk Score |
2.0 | — |
Eligibility Criteria
Inclusion Criteria
- Women who had mammogram and/or ultrasound birads (category IV or V)
- Women ages between 30 and 80.
- Women who have been scheduled for biopsy from the Temple breast surgery clinic
- Women who have been scheduled for biopsy by Dr. Kathleen Reilly.
- Women, who speak and understand English.
Exclusion Criteria
- Women who do not meet the criteria requiring biopsy.
- Women who have allergic reaction to silicone.
- Women who cannot speak or understand English.
- Women who are pregnant.
- Women, younger than 30 years old, and older than 80 years old.
Data sourced from ClinicalTrials.gov (NCT02603211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.