NCT04397029

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: George Washington University · Academic / Other
• Sex: Female
• Age: 30 Years – 80 Years
• Healthy volunteers: Accepted

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).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	SureTouch	The first group will consist of 70 women who are believed to be free of masses, recruited during a screening mammography appointment. The second group will include 125 women presenting for diagnostic mammography and/or biopsy appointment with known masses identified on mammogram, ultrasound or both. Both groups will receive breast cancer screening with mammography and SureTouch.

Timeline

• Start date: 2019-01-04
• Primary completion: 2021-02-10
• Completion: 2021-02-10
• First posted: 2020-05-21
• Last updated: 2022-06-13

Locations

1 site across 1 country: United States