Assessing the Sensitivity of "SureTouch™" in Identifying Clinically Significant Masses in Women Undergoing Diagnostic and Screening Mammography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- George Washington University
- Enrollment
- 213
- Locations
- 1
- Primary Endpoint
- Primary
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Female Subject presenting for screening mammography
- •30-80 years of age, inclusive
- •Able to provide written informed consent
- •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
- •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
Arms & Interventions
Subjects without messes
Subjects who are believed to be free of masses.
Intervention: SureTouch (Device)
Subjects with known masses
Subjects with known masses.
Intervention: SureTouch (Device)
Outcomes
Primary Outcomes
Primary
Time Frame: 2 years
1. This study examines the sensitivity of the SureTouch™ system, compared with methods that are the current standard of care (screening and diagnostic mammography with ultrasound), to detect clinically significant mass lesions in the breast.
Secondary Outcomes
- Secondary(2 years)