Spots Global Cancer Trial Database for Assessing the Sensitivity of "SureTouch™" in Women Undergoing Diagnostic and Screening Mammography
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Trial Identification
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
Conditions
Interventions
Study Description
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).
Keywords
Eligibility
Minimum Age: 30 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
George Washington University - Medical Faculty Associates, Washington, District of Columbia, United States
Contact Details
Name: Rebecca Kaltman, MD
Affiliation: The George Washington University
Role: PRINCIPAL_INVESTIGATOR
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