Evaluation of the Bexa Breast Examination

Part of paid clinical trials in Abilene, Texas.

Sponsor
Sure, Inc.
Study ID
NCT06643767
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
30 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Bexa and focus ultrasound — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Oct 16, 2024
Status verified
Oct 2024
Primary completion
Feb 28, 2025
Completion
May 31, 2025

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Participants
    Participants scheduled for screening mammography.

Primary Outcome Measure

Bexa Sensitivity of Mass Detection [ Time Frame: During procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hendrick Health - Vera West Women's CenterAbileneTexas79601
Danielle Goss, MPH, MHA, CHRC, HEC-C
[email protected]
325-670-2918
John Cole, DO (PRINCIPAL_INVESTIGATOR)

Find similar trials in Abilene, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Hendrick Health - Vera West Women's Center· Abilene, TX

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