U.S., April 2 -- ClinicalTrials.gov registry received information related to the study (NCT07505797) titled 'ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)' on Jan. 06.
Brief Summary: 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) and who have been referred for a biopsy. The goal is to create a comprehensive registry that includes multi-modality breast images alongs...