Actively Recruiting
Evaluation of the Bexa Breast Examination
Led by Sure, Inc. · Updated on 2024-10-18
500
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
Sponsors
S
Sure, Inc.
Lead Sponsor
H
Hendrick Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of the Bexa Breast Examination
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Female, aged 30 to 75 years
You will not qualify if you...
- Women with breast masses smaller than 0.5 cm or larger than 3.5 cm
- Women with palpable breast lesions
- Women with visible breast deformity or skin changes due to clinical findings
- Women with breast tenderness preventing completion of ultrasound or Bexa exams
- Women with significant breast skin scarring preventing effective Bexa exam
- Women with more than 3 positive findings in a single breast
- Women unable or unwilling to provide informed consent
- Women younger than 30 or older than 75 years
- Pregnant women
- Women who have had unilateral or bilateral mastectomy
- Women who have had a breast biopsy in the past 30 days
- Women with prior history of breast cancer
- Women who have had radiation therapy to the breast
- Women who have had breast surgery within the last 12 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hendrick Health - Vera West Women's Center
Abilene, Texas, United States, 79601
Actively Recruiting
Research Team
D
Danielle Goss, MPH, MHA, CHRC, HEC-C
CONTACT
J
Johanna Garzon, MHA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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