MedTrace Logo

Technology Development of Diagnostic Ultrasound System for Obstetric Imaging

NCT07590063 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • Pregnancy

Interventions

DEVICE

Diagnostic Ultrasound System

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

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER

  • United Imaging Healthcare North America, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-06
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07590063 on ClinicalTrials.gov