RecruitingNot ApplicableNCT06643767

Evaluation of the Bexa Breast Examination

Evaluation of the Bexa Breast Examination (BBE) As an Effective Solution to Breast Cancer Early Detection

Sponsor

Sure, Inc.

Enrollment

500 participants

Start Date

Oct 16, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 30 YearsMax Age: 75 Years

Inclusion Criteria4

Women who present to receive a screening mammogram.
Women of all races, ethnicities, and socio-economic backgrounds.
Signed informed consent obtained prior to any study assessments and procedures.
Age 30-75 years of age and female.

Exclusion Criteria14

Women with findings that are \< 0.5 cm or \> 3.5 cm
Palpable lesion (to the participant)
Positive clinical findings that cause a visible and obvious deformity of the breast or alteration in the skin appearance of the breast.
Women with breast tenderness significant enough to prevent completion of any of the study examinations. (Both ultrasound and Bexa require a light degree of pressure on the breast; certain women, very few, have enough breast tenderness that they cannot tolerate the pressure of either Bexa or ultrasound. Mammograms exert substantially more pressure on the breast.)
Women with breast significant skin scarring enough to prevent effective BBE (e.g., keloid scarring of the breast, for example), because extensive, hard surface scarring introduces artifact in the Bexa exam. Participant exclusion will be determined by the Bexa examiner.
Greater than 3 positive findings in a given breast.
Women who are unable to comprehend or unwilling to sign an informed consent form.
Women ages \< 30 and \> 75 years of age.
Pregnant women.
Women who have had a mastectomy - unilateral or bilateral.
Women who have had a recent (past 30 days) biopsy performed.
Women who have had a prior history of breast cancer in either breast.
Women who have had radiation to the breast.
Women who have had any breast surgery within the last 12 months.

Interventions

DEVICEBexa 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.