MedTrace Logo

Evaluation of the Bexa Breast Examination

NCT06643767 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2024-10-18

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Hendrick Medical Center

    collaborator OTHER

  • Sure, Inc.

    lead INDUSTRY

Principal Investigators

  • John Cole, DO · Hendrick Health

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-16
Primary Completion
2025-02-28
Completion
2025-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06643767 on ClinicalTrials.gov