ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)
Recruiting
Observational Study
Breast Cancer
Benign Breast Condition
Breast Fibroadenoma
Breast Neoplasms
Breast Disease
Breast Cancer Female
Breast Pain
Breast Cancer Invasive
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 – 94
- Sex
- Female
- Study type
- Observational
- Participants needed
- 800 (estimated)
- Sponsor
- iSono Health, Inc. · Industry
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About This Trial
AUDIBLE is a multi-site, clinical study conducted in the United States aimed at gathering data on 3D Automated Breast Ultrasound imaging using the iSono Health ATUSA system. The study focuses on female participants who have previously been identified with suspicious findings (classified as BIRADs 4 or 5) through standard-of-care diagnostic imaging methods (e.g., hand-held ultrasound, mammograms) a…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Provide written informed consent through a signed and dated consent form.
2. Demonstrate commitment to complete all study requirements and maintain availability for the full study duration.
3. Be female, aged 18 to 94 years (inclusive).
4. Have a recent BI-RADS® 4 or 5 classi…
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