Fetus DisorderNCT07601191
AutoFUSE or First-Trimester Ultrasound Scan
A study testing AutoFUSE system and Traditional ultrasound scan in people with Fetus Disorder, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetus Disorder
- What is being tested?
- AutoFUSE system and Traditional ultrasound scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jun 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ① Pregnant women undergoing fetal ultrasound examination.
- ② A singleton pregnancy with a live fetus between 11 and 13+6 weeks with complete outcomes.
Who cannot join
- Incomplete pregnancy outcome information.
- Unexplained miscarriages. ③ Fetal death.
- Pregnancies with significant maternal complications.
- Multiple pregnancies.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Wuhan Union Hospital
Wuhan, Hubei, 430022
Lei Chen, MD, 15971480677, chan0812@126.com
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430022
Huangxuan Zhao, PhD, 18971676985, zhao_huangxuan@sina.com
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Yong Luo, PhD, 15210624692, chan0812@126.com
About this study
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
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.
Read more
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.
- Conditions
- Fetus Disorder
- Being tested
- AutoFUSE system, Traditional ultrasound scan
- Keywords
- First-trimester ultrasound, Artificial intelligence, Standard plane, Image quality control, Randomized clinical trial
- Medical subject headings
- Fetal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoFUSE systemDiagnostic test
AutoFUSE is an AI-based intelligent image quality control system independently developed for first-trimester fetal ultrasound scan (FTFUS).
Traditional ultrasound scanDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| AutoFUSE-assisted ultrasound scan | Experimental | AutoFUSE-assisted ultrasound scanning throughout the examination. Receives: Diagnostic Test: AutoFUSE system |
| Traditional ultrasound scan | Active comparator | Standard ultrasound scanning according to the standard clinical protocol. Receives: Diagnostic Test: Traditional ultrasound scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetus DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601191
- Sponsor's protocol ID
- AutoFUSE-001
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07601191
- Acronym / sponsor ID
- AutoFUSE-001
- Conditions
- Fetus Disorder
- Keywords
- First-trimester ultrasound, Artificial intelligence, Standard plane, Image quality control, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AutoFUSE-assisted ultrasound scan | Experimental | Diagnostic Test: AutoFUSE systemAutoFUSE-assisted ultrasound scanning throughout the examination. |
| Traditional ultrasound scan | Active comparator | Diagnostic Test: Traditional ultrasound scanStandard ultrasound scanning according to the standard clinical protocol. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- ① Pregnant women undergoing fetal ultrasound examination.
- ② A singleton pregnancy with a live fetus between 11 and 13+6 weeks with complete outcomes.
Key exclusion criteria (4 listed)
- Incomplete pregnancy outcome information.
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 |
|---|---|---|
| AutoFUSE systemAutoFUSE is an AI-based intelligent image quality control system independently developed for first-trimester fetal ultrasound scan (FTFUS). | Diagnostic test | AutoFUSE-assisted ultrasound scan |
| Traditional ultrasound scanTraditional 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. | Diagnostic test | Traditional ultrasound scan |
Primary outcome
The efficiency of standard plane acquisition
Time frame: Day 1
The primary outcome was measured by the time required to obtain the prespecified standard planes during the ultrasound examination.
1 secondary outcome
The accuracy of standard plane acquisition
Time frame: Through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AutoFUSE system and Traditional ultrasound scan in people with Fetus Disorder, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 3 sites in China.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficiency of standard plane acquisition (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 22 May 2026.