PregnancyNCT07590063
Technology Development of Diagnostic Ultrasound System for Obstetric Imaging
An observational study of Pregnancy, run by United Imaging Healthcare North America, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Diagnostic Ultrasound System
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2026to 17 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant persons aged 18-45 years with single intrauterine pregnancy at 18-28 weeks gestational age presenting for obstetric care at Oregon Health \& Science University, Portland, Oregon
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Perinatology and Genetics Clinic
Portland, Oregon, 97239
About this study
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
- Being tested
- Diagnostic Ultrasound System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Ultrasound SystemDevice
Also called UIH uSONIQUE
Investigational diagnostic ultrasound system used to perform fetal anatomic survey of the maternal abdomen.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Participants | Pregnant persons aged 18-45 years with single intrauterine pregnancy at 18-28 weeks of gestational age undergoing obstetric ultrasound at OHSU Receives: Device: Diagnostic Ultrasound System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Fetal Biometric Image Set Collection
Number of participants from whom complete fetal biometric image sets are successfully collected, including Biparietal Diameter (BPD), Head Circumference (HC), Abdominal Circumference (AC), and Femur Length (FL), in compliance with the study scanning protocol standards
Measured: Day 1
Secondary outcomes (2)
Reference Dataset Creation
Completion of independent reviews by two qualified obstetricians, resolution of measurement discrepancies through adjudication, and establishment of final ground truth measurements for all collected biometric data
Measured: Within 4 months of study completion
Incidence of Adverse Events
Nature, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs), including device-related complications and study discontinuations
Measured: Throughout study participation, up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start20 May 2026
- Primary completion20 Jul 2026
- Study completion17 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Imaging Healthcare North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590063
- Sponsor's protocol ID
- UIH-OB-US-2026-001
- Other IDs
- IRB 29935
- Status last verified
- Oct 2026
- First submitted
- 4 May 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a proprietary dataset for UIH's 510(k) submission and is not intended for public sharing
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Development of Diagnostic Ultrasound System for Obstetric Imaging
- ClinicalTrials.gov ID
- NCT07590063
- Acronym / sponsor ID
- UIH-OB-US-2026-001
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- United Imaging Healthcare North America, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University
- Study start
- 20 May 2026 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 17 Sep 2026 (actual)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Participants | – | Device: Diagnostic Ultrasound SystemPregnant persons aged 18-45 years with single intrauterine pregnancy at 18-28 weeks of gestational age undergoing obstetric ultrasound at OHSU |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant persons aged 18-45 years with single intrauterine pregnancy at 18-28 weeks gestational age presenting for obstetric care at Oregon Health \& Science University, Portland, Oregon
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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:
- Patients with serious medical comorbidities including: maternal congenital heart abnormalities; history of organ transplant; asthma exacerbation (during pregnancy); pre-eclampsia; recent mechanical trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Ultrasound SystemAlso: UIH uSONIQUEInvestigational diagnostic ultrasound system used to perform fetal anatomic survey of the maternal abdomen. | Device | Pregnant Participants |
Primary outcome
Complete Fetal Biometric Image Set Collection
Time frame: Day 1
Number of participants from whom complete fetal biometric image sets are successfully collected, including Biparietal Diameter (BPD), Head Circumference (HC), Abdominal Circumference (AC), and Femur Length (FL), in compliance with the study scanning protocol standards
2 secondary outcomes
Reference Dataset Creation
Time frame: Within 4 months of study completion
Incidence of Adverse Events
Time frame: Throughout study participation, up to 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No. This is a proprietary dataset for UIH's 510(k) submission and is not intended for public sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by United Imaging Healthcare North America, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Fetal Biometric Image Set Collection (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.