AutoFUSE or First-Trimester Ultrasound Scan
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.
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Hubei
-
Wuhan, Hubei, Kina, 430022
- Wuhan Union Hospital
-
Ta kontakt med:
- Lei Chen, MD
- Telefonnummer: 15971480677
- E-post: chan0812@126.com
-
Wuhan, Hubei, Kina, 430060
- Renmin Hospital of Wuhan University
-
Ta kontakt med:
- Yong Luo, PhD
- Telefonnummer: 15210624692
- E-post: chan0812@126.com
-
Wuhan, Hubei, Kina, 430022
- Zhongnan Hospital of Wuhan University
-
Ta kontakt med:
- Huangxuan Zhao, PhD
- Telefonnummer: 18971676985
- E-post: zhao_huangxuan@sina.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: AutoFUSE-assisted ultrasound scan
AutoFUSE-assisted ultrasound scanning throughout the examination.
|
AutoFUSE is an AI-based intelligent image quality control system independently developed for first-trimester fetal ultrasound scan (FTFUS).
|
|
Aktiv komparator: Traditional ultrasound scan
Standard ultrasound scanning according to the standard clinical protocol.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The efficiency of standard plane acquisition
Tidsramme: Day 1
|
The primary outcome was measured by the time required to obtain the prespecified standard planes during the ultrasound examination.
|
Day 1
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The accuracy of standard plane acquisition
Tidsramme: Through study completion, an average of 6 months
|
The secondary outcome was assessed by whether the prespecified standard planes are correctly obtained according to predefined imaging criteria.
|
Through study completion, an average of 6 months
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AutoFUSE-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .