Evaluation of the Bexa Breast Examination

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.

This description comes directly from the study's public registry record.

Danielle Goss, MPH, MHA, CHRC, HEC-C  ·  325-670-2918  ·  dgoss@hendrickhealth.org

Johanna Garzon, MHA  ·  325-670-4464  ·  jgarzoncastro@hendrickhealth.org

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