Evaluation of Scanning and Diagnostic Performance of an Autonomous Dual-Arm Breast Ultrasound Robot

Condition(s) studied

Investigational drug(s) / intervention(s)

Autonomous Dual-Arm Robotic Breast Ultrasound: Participants will undergo autonomous dual-arm robotic breast ultrasound after conventional handheld ultrasound. The system will autonomously perform breast scanning and acquire ultrasound images for subsequent evaluation of imaging and diagnostic performance. The robotic ultrasound results will not be used to guide clinical management.

Study summary

This prospective, multicenter, intraindividual paired study aims to evaluate the autonomous scanning performance of a dual-arm robotic breast ultrasound system and the diagnostic performance of the images it acquires, in comparison with conventional handheld ultrasound. The study primarily focuses on the agreement between diagnostic assessments based on images obtained using the two examination methods, while also evaluating image quality, lesion detection, and measurement performance. The robotic ultrasound findings will be collected for research purposes only and will not be used to guide clinical management; all clinical decisions will be based on routine clinical assessment.

Eligibility

Primary outcome measure(s)

• Agreement Between Expert BI-RADS Classifications Based on Robotic and Handheld Breast Ultrasound Images — 6 weeks after completion of image collection for all participants

Trial sites (4)

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