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NCT06643767 · ClinicalTrials.gov registry record · NA
Evaluation of the Bexa Breast Examination
A NA study of Breast Cancer, sponsored by Sure.
- Recruiting
- Registry status
- NA
- Development phase
- 500
- Enrollment target
- 1
- Study location
NCT06643767: Recruiting NA study of Breast Cancer, sponsored by Sure.
NCT06643767 is a NA study of Breast Cancer that is actively recruiting participants, run by Sure. The registered enrollment target is 500 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06643767, a NA study of Breast Cancer, is actively recruiting participants, sponsored by Sure.
- RECRUITING
- Registry status
- NA
- Development phase
- 500 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DEVICE Bexa and focus ultrasound
Study Locations (1)
Texas
- Hendrick Health - Vera West Women's Center - Abilene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2024-10-16 |
| Est. Completion | 2025-05-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06643767
The ClinicalTrials.gov registry entry for NCT06643767 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (82% lower). The listed sponsor is Sure, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Bexa and focus ultrasound is the first listed.
NCT06643767 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06643767 about?
NCT06643767 is a clinical study titled "Evaluation of the Bexa Breast Examination". 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 foc...
What is the current status of trial NCT06643767?
This trial is currently recruiting. It is a NA study. The enrollment target is 500 participants. The study started on 2024-10-16. Estimated completion is 2025-05-31.
What conditions does trial NCT06643767 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT06643767?
The interventions under investigation include: Bexa and focus ultrasound (DEVICE).
Who is sponsoring clinical trial NCT06643767?
This trial is sponsored by Sure, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06643767 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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