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NOT YET RECRUITING
NCT07590063

Technology Development of Diagnostic Ultrasound System for Obstetric Imaging

Sponsor: United Imaging Healthcare North America, Inc.

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2026-05-06

Completion Date

2026-09-30

Last Updated

2026-05-15

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Diagnostic Ultrasound System

Investigational diagnostic ultrasound system used to perform fetal anatomic survey of the maternal abdomen.

Locations (1)

OHSU Perinatology and Genetics Clinic

Portland, Oregon, United States