Assessing the Sensitivity of "SureTouch™" in Women Undergoing Diagnostic and Screening Mammography
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About
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.
Full 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).
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
213 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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