Technology Development of Diagnostic Ultrasound System for Obstetric Imaging

This study collects obstetric ultrasound images from pregnant participants using the UIH uSONIQUE Nova diagnostic ultrasound system (uC7-1s transducer). The goal is to obtain standardized, high-quality images to support artificial intelligence (AI) algorithm development, AI training and validation, and automated obstetric measurement workflows. Results will support a premarket notification (510(k)) submission to the U.S. FDA.

NCT Number	NCT07590063
Lead Sponsor	United Imaging Healthcare North America, Inc. Collaborators: Oregon Health and Science University
Conditions	Pregnancy
Enrollment	50 participants
Start Date	2026-05-06
Primary Completion	2026-09-30 (estimated)
Study Completion	2026-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-15