Sponsor study identifier
interventional
1,000
1 country
3
Study Start
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 10, 2026
Actual (reported)May 22, 2026
Actual (reported)June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Day 1
The accuracy of standard plane acquisition
Through study completion, an average of 6 months
AutoFUSE-assisted ultrasound scanning throughout the examination.
Standard ultrasound scanning according to the standard clinical protocol.
AutoFUSE is an AI-based intelligent image quality control system independently developed for first-trimester fetal ultrasound scan (FTFUS).
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.
Wuhan Union Hospital
Wuhan, Hubei, 430022, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430022, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
First Submitted
May 10, 2026
First Posted
May 22, 2026
Study Start
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 31, 2026
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 22, 2026
Record last verified: 2026-05
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Source: ClinicalTrials.gov.
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