Health TrialsbyHealthPanel

AutoFUSE or First-Trimester Ultrasound Scan

ConditionFetus Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Incomplete pregnancy outcome information.

Unexplained miscarriages. ③ Fetal death.

Pregnancies with significant maternal complications.

Multiple pregnancies.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AutoFUSE system

    Diagnostic test

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

  • Traditional ultrasound scan

    Diagnostic test

    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.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: AutoFUSE-assisted ultrasound scanExperimental treatment 1 intervention
Group B: Traditional ultrasound scanActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The efficiency of standard plane acquisition

The primary outcome was measured by the time required to obtain the prespecified standard planes during the ultrasound examination.

Time frame
Day 1

Secondary outcomes

1

The accuracy of standard plane acquisition

The secondary outcome was assessed by whether the prespecified standard planes are correctly obtained according to predefined imaging criteria.

Time frame
Through study completion, an average of 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: