Assessing the Sensitivity of "SureTouch™" in Women Undergoing Diagnostic and Screening Mammography
- Conditions
- Breast Cancer
- Interventions
- Device: SureTouch
- Registration Number
- NCT04397029
- Lead Sponsor
- George Washington University
- 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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 213
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Subjects without messes SureTouch Subjects who are believed to be free of masses. Subjects with known masses SureTouch Subjects with known masses.
- Primary Outcome Measures
Name Time Method Primary 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 Outcome Measures
Name Time Method Secondary 2 years The study will determine the patient acceptance of and satisfaction with the SureTouch devise. Outcome measure will use an original 8 question Likert-scale survey to assess patient perception of the comfort, duration, and acceptance of the device. A higher score indicates a better outcome.
Brief Survey Monkey adapted from Press Ganey Patient Satisfaction Survey for Radiography and US Performed in the Outpatient Setting. Itri JN. Patient-centered Radiology. RadioGraphics 2015; 35:1835-1848
Trial Locations
- Locations (1)
George Washington University - Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States