Ignite Creation Date:
2024-05-06 @ 2:52 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04441866
Status:
COMPLETED
Last Update Posted:
2021-06-14
First Post:
2020-06-17
Brief Title:
Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound
Sponsor:
Università degli Studi di Brescia
Organization:
Università degli Studi di Brescia
Study Overview
Official Title:
Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Auto-2T
Brief Summary:
This study aims to evaluate the effect of the use of automated algorithms for the measurement of fetal biometry and for the reconstruction of standard planes of fetal anatomy compared with the standard ultrasound technique during the second trimester ultrasound scan
Detailed Description:
In recent years in many ultrasound equipment were fitted with automated algorithms for measuring fetal biometry and for the reconstruction of standard planes of fetal anatomy Although there are studies that have assessed the application of these algorithms in terms of repeatability of the measurements made or of possibility of acquiring diagnostic planes there are no randomized controlled studies that evaluated their impact on the second trimester ultrasound scan
The aim of the study is to evaluate the effect of the use of automated algorithms for the measurement of fetal biometry and for the reconstruction of standard planes of fetal anatomy compared with the standard ultrasound technique in terms of
duration of the ultrasound scan
quality of biometric measurements
quality of the diagnostic planes
operator satisfaction
The aim of the study is to evaluate the effect of the use of automated algorithms for the measurement of fetal biometry and for the reconstruction of standard planes of fetal anatomy compared with the standard ultrasound technique in terms of
duration of the ultrasound scan
quality of biometric measurements
quality of the diagnostic planes
operator satisfaction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None