AutoFUSE or First-Trimester Ultrasound Scan

Condition(s) studied

Investigational drug(s) / intervention(s)

AutoFUSE system: AutoFUSE is an AI-based intelligent image quality control system independently developed for first-trimester fetal ultrasound scan (FTFUS).

Traditional ultrasound scan: Traditional ultrasound scan means the standard clinical ultrasound examination performed by sonographers using routine manual operation to acquire predefined standard anatomical planes, without real-time AI assistance, automatic plane recognition, or automatic image quality assessment. All plane acquisition and quality evaluation are completed manually by the operator.

Study 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.

Eligibility

Primary outcome measure(s)

• The efficiency of standard plane acquisition — Day 1
  The primary outcome was measured by the time required to obtain the prespecified standard planes during the ultrasound examination.

Trial sites (3)

More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China