Technology Development of Diagnostic Ultrasound System for Obstetric Imaging

Part of paid clinical trials in Portland, Oregon.

Sponsor
United Imaging Healthcare North America, Inc.
Study ID
NCT07590063
Status
Not Yet Recruiting

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Conditions

  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Diagnostic Ultrasound System — DEVICE
    Investigational diagnostic ultrasound system used to perform fetal anatomic survey of the maternal abdomen.

Study Details

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 Dates

Start date
May 6, 2026
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Pregnant Participants
    Pregnant persons aged 18-45 years with single intrauterine pregnancy at 18-28 weeks of gestational age undergoing obstetric ultrasound at OHSU

Primary Outcome Measure

Complete Fetal Biometric Image Set Collection [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Perinatology and Genetics ClinicPortlandOregon97239
Adam Crosland, MD, MPH
[email protected]
503-494-6852

Find similar trials in Portland, OR

By research site
OHSU Perinatology and Genetics Clinic· Portland, OR

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