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Brief Title: Assessing the Sensitivity of "SureTouch™" in Women Undergoing Diagnostic and Screening Mammography
Official Title: Assessing the Sensitivity of "SureTouch™" in Identifying Clinically Significant Masses in Women Undergoing Diagnostic and Screening Mammography
Study ID: NCT04397029
Brief Summary: Prospective, case-control study being conducted to determine the sensitivity of the SureTouch device in detecting known masses at a pre-determined level of specificity.
Detailed Description: This is a single-center, prospective, case-control study being conducted to determine the sensitivity of the SureTouch device in detecting known masses at a pre-determined level of specificity. Results of the mammography will be compared to the SureTouch examination results. Subjects will have between 1 and 3 research visits and 3 follow-up surveys, up to two years from the initial visit. The number of visits will be based upon comparison of the SureTouch examination to conventional breast screening techniques (mammogram and ultrasound).
Minimum Age: 30 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
George Washington University - Medical Faculty Associates, Washington, District of Columbia, United States
Name: Rebecca Kaltman, MD
Affiliation: The George Washington University
Role: PRINCIPAL_INVESTIGATOR