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Evaluation of the Bexa™ Breast Examination (BBE)

NCT05882019 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2023-05-31

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 ("spot ultrasound") to identify and further evaluate abnormal breast masses including cancer. Commercially, this combination of Bexa plus focused ultrasound is called "Bexa Plus." This study compares the use of the Bexa Breast Exam (BBE/Bexa Plus) as a breast cancer early detection examination with the current standard of care digital breast tomosynthesis.

The specific objectives are:

1. To measure the sensitivity and specificity of BBE as compared to digital breast tomosynthesis.
2. Measure the proportion of women receiving a Bexa Breast Exam that require additional imaging studies.

Hypothesis The purpose of this study is to demonstrate that Bexa Breast Examination's sensitivity and specificity in identifying abnormal breast masses are equal to or superior than the standard accepted mammography with tomosynthesis.

Conditions

Interventions

DEVICE

Breast Exam with Bexa

Breast exam with Bexa uses pressure elastography to produce a map of the breast tissue's elasticity.

Sponsors & Collaborators

  • MaineHealth

    collaborator OTHER

  • Sure, Inc.

    lead INDUSTRY

Principal Investigators

  • Christina Cinelli, MD · Maine Health

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2023-09-30
Completion
2023-12-31
FDA Device
Yes

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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 NCT05882019 on ClinicalTrials.gov