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Assessing the Sensitivity of "SureTouch™" in Identifying Clinically Significant Masses in Women Undergoing Diagnostic and Screening Mammography
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.
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).
Age
30 - 80 years
Sex
FEMALE
Healthy Volunteers
Yes
George Washington University - Medical Faculty Associates
Washington D.C., District of Columbia, United States
Start Date
January 4, 2019
Primary Completion Date
February 10, 2021
Completion Date
February 10, 2021
Last Updated
June 13, 2022
213
ACTUAL participants
SureTouch
DEVICE
Lead Sponsor
George Washington University
Collaborators
NCT05372640
NCT04704661
Data Source & Attribution
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