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RECRUITING
NCT06643767
NA

Evaluation of the Bexa Breast Examination

Sponsor: Sure, Inc.

View on ClinicalTrials.gov

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

DEVICE

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