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Not yet recruiting NCT07590063

Technology Development of Diagnostic Ultrasound System for Obstetric Imaging

— Observational Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diagnostic Ultrasound System.
Who it may be relevant to
Registry conditions: Pregnancy. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Complete Fetal Biometric Image Set Collection [Time frame: Day 1]
Secondary outcome measures (2)
  • Reference Dataset Creation [Time frame: Within 4 months of study completion]
  • Incidence of Adverse Events [Time frame: Throughout study participation, up to 4 months]

Eligibility criteria

Inclusion criteria

To be eligible to participate in this study, an individual must meet all of the following criteria:

  • Pregnant persons age 18-45 years
  • Single intrauterine pregnancy
  • Gestational duration: 18 - 28 weeks

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Pregnant individuals with multi-fetal gestation (e.g., twins, triplets, etc.).
  • Pregnant individuals with suspected or known fetal anomaly, undergoing evaluation for genetic abnormality, requiring non-standard care, or diagnostic intervention.
  • Pregnant individuals with a medical or surgical history that may impact quality of ultrasound imaging:
  • Body Mass Index (BMI) > 40
  • Prior surgeries including: abdominal mesh placement; abdominoplasty
  • Vaginal bleeding within the last 6 weeks
  • Patients with serious medical comorbidities including: maternal congenital heart abnormalities; history of organ transplant; asthma exacerbation (during pregnancy); pre-eclampsia; recent mechanical trauma.
  • Use of any of the following during pregnancy: marijuana (or similar derivatives); alcohol; tobacco; methamphetamines; warfarin; isotretinoin; methotrexate; valproic acid; retinoids; oral steroids
  • Non-English speaking.
  • Participants deemed unsuitable by the investigator due to safety or data integrity.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • OHSU Perinatology and Genetics Clinic — Portland

Identifiers

NCT: NCT07590063 · UIH-OB-US-2026-001 · IRB 29935

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗