Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-29 @ 10:18 PM
Study NCT ID:
NCT05538403
Status:
UNKNOWN
Last Update Posted:
2022-09-13
First Post:
2022-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI Performance for the Detection of Bone Fractures in Children
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
Assessment of AI Performance for the Detection of Bone Fractures in Children Aged Less Than 2 Years Old in Suspected Child Abuse Setting.
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
RECRUITING
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:
None
Brief Summary:
The artificial intelligence (AI) software BoneView (GLEAMER Company, Paris, France) has been designed, tested and validated to detect and locate recent or semi-recent fractures on standard radiographs.
The objective will be to assess the AI performance for the detection of bone fractures in children aged less than 2 years old in suspected child abuse setting.
These patients benefit from a whole body radiography with a double blind reading by a "generalist" radiologist and a radiologist with expertise in child abuse. This readings will be compared with the AI results.
Hypothesis is that AI is effective for child fractures detection and could be of help especially for radiologists who are not experts in child abuse.
The objective will be to assess the AI performance for the detection of bone fractures in children aged less than 2 years old in suspected child abuse setting.
These patients benefit from a whole body radiography with a double blind reading by a "generalist" radiologist and a radiologist with expertise in child abuse. This readings will be compared with the AI results.
Hypothesis is that AI is effective for child fractures detection and could be of help especially for radiologists who are not experts in child abuse.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: