Status:
COMPLETED
Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition
Lead Sponsor:
Philips Electronics Nederland B.V. acting through Philips CTO organization
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
In the proposed clinical investigation, the investigational device (BabySize3D) will provide automated plane extraction and automated biometry measurements from 3D US volumes. The results obtained fro...
Eligibility Criteria
Inclusion
- evolutive pregnancy with one fetus with a Gestational Age between 16 and 30 weeks
- aged between 18 and 65 years.
- social welfare benefit recipient
- willing and able to provide informed consent
Exclusion
- under 18 years old
- multiple pregnancy
- over 18 years old and mentioned in French law articles L.1126-6 et L-1126-8,
- fetal malformation or suspected fetal malformation
- technical conditions that do not allow for standard fetal biometry (abdominal wall, fetal position, BMI \> 25 kg/m2)
- fetal biometry non indicated in the standard pregnancy follow-up
- unwilling or unable to provide informed consent (e. g. physical, mental disability or linguistic factor that compromises patient information)
Key Trial Info
Start Date :
October 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2023
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT03812471
Start Date
October 23 2018
End Date
March 17 2023
Last Update
April 14 2023
Active Locations (1)
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1
CHRU de Nancy Brabois
Nancy, France, 54511