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Evaluation of the Bexa Breast Examination
Sponsor: Sure, Inc.
Summary
Objective: The "Bexa Breast Exam," or "BBE," for the purposes of this study is defined as the use of a Bexa device in conjunction with a portable, focused ultrasound examination to identify and further evaluate abnormal breast masses including cancer. Commercially, this combination of Bexa plus focused ultrasound is called "Bexa Breast ExamTM," and abbreviated as, "BBE." This study compares the Bexa Breast Exam (BBE) to the standard of care (digital breast tomosynthesis) in detecting masses and as a breast cancer early detection examination. The specific objectives are: 1. To measure the sensitivity and specificity of BBE as compared to digital breast tomosynthesis in the general population of women over 30 without a history of breast cancer. 2. To measure the sensitivity and specificity of BBE as compared to digital breast tomosynthesis identifying breast masses including cancer in women with dense breasts. 3. To demonstrate the proportion of women receiving a BBE that require additional imaging studies. Hypothesis: The purpose of this study is to demonstrate that the Bexa Breast Examination's sensitivity and specificity in identifying abnormal breast masses is comparable to the current accepted standard of care, mammography with tomosynthesis.
Official title: Evaluation of the Bexa Breast Examination (BBE) as an Effective Solution to Breast Cancer Early Detection
Key Details
Gender
FEMALE
Age Range
30 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2024-10-16
Completion Date
2025-05-31
Last Updated
2024-10-18
Healthy Volunteers
Yes
Conditions
Interventions
Bexa and focus ultrasound
The Bexa exam uses pressure elastography to produce a map of the breast tissue's elasticity to identify any masses. Focused ultrasound is then used to further classify the mass into a BIRADS category.
Locations (1)
Hendrick Health - Vera West Women's Center
Abilene, Texas, United States