ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) - iSono Health

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 alongside and biopsy results.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Breast Cancer
• Benign Breast Condition
• Breast Fibroadenoma
• Breast Neoplasms
• Breast Disease
• Breast Cancer Female
• Breast Pain
• Breast Cancer Invasive
• Breast Cancer Detection

Eligibility basics and study details

Study type

Observational

Phase

Not applicable

Ages

18 to 94 years

Sex

Female

Healthy volunteers

Not accepted

Sponsor

iSono Health, Inc.

Last updated on ClinicalTrials.gov

September 17, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites