Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06152289
Status:
RECRUITING
Last Update Posted:
2023-11-30
First Post:
2023-06-06
Brief Title:
Development of New Diagnostic Tools in Capsule Endoscopy
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Development of New Diagnostic Tools in Capsule Endoscopy
Status:
RECRUITING
Status Verified Date:
2023-11
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:
NOCE
Brief Summary:
Patients participating to this study will provide images and videos of capsule endoscopy to train tune and evaluate technological bricks of artificial intelligence solutions in order to improve diagnostic performances of the procedure while reducing reading time by physicians
Detailed Description:
Capsule endoscopy is a minimally-invasive diagnostic procedure based on the ingestion or endoscopic delivery of a miniaturized biocompatible camera Capsules capture tenths of thousands images of the digestive tract Reading the captured images and reporting is long tedious and at risk of errors when the readers attention is disturbed Artificial intelligence is expected to alleviate these limitations by both improving diagnostic performances of capsule endoscopy while reducing reading time
Any patient in whom a capsule endoscopy examination is performed as part of routine care will be invited to participate to the study Their de-identified images and videos will be extracted thus allowing the creation of several databases for training tuning and testing technological bricks of artificial intelligence Basic clinical data will be collected age gender indication for capsule endoscopy type of device ingestion or delivery of capsule Images and videos will be characterized centrally and consensually by a panel of 3 expert readers according to their level of relevance in relation to the type and indication of capsule endoscopy
The various developed technological bricks will aim to automatically detect and characterize anatomical landmarks and abnormal findings and to quote the intestine cleanliness
Assessment of diagnostic performance and reading time will be performed within a few months or up to five years for each technological brick individually and then combined according to their stepwise development
Any patient in whom a capsule endoscopy examination is performed as part of routine care will be invited to participate to the study Their de-identified images and videos will be extracted thus allowing the creation of several databases for training tuning and testing technological bricks of artificial intelligence Basic clinical data will be collected age gender indication for capsule endoscopy type of device ingestion or delivery of capsule Images and videos will be characterized centrally and consensually by a panel of 3 expert readers according to their level of relevance in relation to the type and indication of capsule endoscopy
The various developed technological bricks will aim to automatically detect and characterize anatomical landmarks and abnormal findings and to quote the intestine cleanliness
Assessment of diagnostic performance and reading time will be performed within a few months or up to five years for each technological brick individually and then combined according to their stepwise development
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