Overview
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.
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).
Eligibility
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