AutoFUSE or First-Trimester Ultrasound Scan

ClinicalTrials.gov ID

NCT07601191

Lead Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

1,000Estimated

Last Update Posted

May 22, 2026Actual

Start Date

Jun 1, 2026Estimated

Primary Completion Date

Oct 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

Official Title

Validation of an AI-based Intelligent Image Quality Control System for First-Trimester Ultrasound Scan: a Stepwise, Multicenter, Randomized Clinical Trial in China

Brief Summary

The goal of this clinical trial is to validate the clinical application capabilities of AutoFUSE. The main questions it aims to answer are:

Does AutoFUSE reduce the time required to obtain standard planes in first-trimester ultrasound scan? Does AutoFUSE improve the accuracy of standard plane acquisition in first-trimester ultrasound scan? What safety outcomes occur in participants undergoing AutoFUSE-assisted ultrasound examination? Researchers will compare AutoFUSE-assisted ultrasound scan with standard clinical protocol (SCP) ultrasound scan to evaluate the efficacy and safety of AutoFUSE in clinical practice.

Participants will:

Undergo either AutoFUSE-assisted ultrasound scan or standard clinical ultrasound scan according to the study design.

Complete scheduled visits for examinations, data collection and follow-up. Provide information related to scan time, image quality and safety during the study.

• Fetus Disorder

• AutoFUSE system
• Traditional ultrasound scan

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

① Pregnant women undergoing fetal ultrasound examination.

② A singleton pregnancy with a live fetus between 11 and 13+6 weeks with complete outcomes.

Exclusion Criteria:

• Incomplete pregnancy outcome information.

  • Unexplained miscarriages. ③ Fetal death.

    • Pregnancies with significant maternal complications.

      • Multiple pregnancies.

Primary Purpose

Diagnostic

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyOTHER

zhao_huangxuan@sina.com18971676985

chan0812@126.com15210624692

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