Assessing the Sensitivity of "SureTouch™" in Women Undergoing Diagnostic and Screening Mammography

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).

Inclusion Criteria:

Arm 1:

• Female Subject presenting for screening mammography
• 30-80 years of age, inclusive
• Able to provide written informed consent

Arm 2:

• Female Subject presenting for diagnostic appointment and/or biopsy
• 30-80 years of age, inclusive
• 1-3 masses per breast
• Masses between 0.5 cm and 3.5 cm only

Exclusion Criteria:

• Individuals who are unable to comprehend or unwilling to sign an informed consent form
• Women younger than 30 or older than 80
• Pregnant women
• Women who have undergone bilateral mastectomies
• Males
• Prisoners
• Masses which are larger than 3.5 cm or smaller than 0.5 cm in size
• Individuals with more than 3 masses per breast will be excluded due to the complexity of these cases