Ignite Creation Date:
2024-05-06 @ 2:41 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04399590
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2020-05-19
Brief Title:
Comparing the Number of False Activations Between Two Artificial Intelligence CADe Systems the NOISE Study
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
Comparing the Number of False Activations Between Two Artificial Intelligence CADe Systems the NOISE Study
Status:
COMPLETED
Status Verified Date:
2021-09
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:
NOISE
Brief Summary:
One fourth of colorectal neoplasias are missed during screening colonoscopies-these can develop into colorectal cancer CRC In the last couple of years Artificial Intelligence Deep learning systems were introduced in the endoscopic setting to allow for real-time computer-aided detectioncharacterization CAD of polyps with high- accuracy Few CADe detection and CADx diagnosis characterization have been therefore proposed with this purpose Because CAD systems are based on deep learning where the computer directly learns polyp recognition from supervised data without any human-control on the final algorithm their outcome incorporates some unpredictability in the clinical setting that must be cautiously interpreted after its application This means that the endoscopist may be presented with FP images that he would have never been selected in the first place as suspicion areas These FPs may hamper the efficiency of CADe-colonoscopy Additional time may be required to discriminate between an actual FP and a possible false negative result An excess of FPs may reduce the motivation of the endoscopist for CADe leading to its underuse in clinical practice Although the indications of a CADe must always be interpreted by physician FP may result in unnecessary polypectomy with related adverse events when used without appropriate training Yet there is a lack of information among quantity and quality of False Positive signals provided by the systems From a post-hoc analysis of a Randomized Clinical Trial in which we extracted and analysed a video library of CADe-colonoscopy GI Genius performed in our institution Humanitas Clinical and Research Hospital IRCCS we aimed that False positives by CADe are primarily due to artefacts from the bowel wall Despite a high frequency FPs from this CADe system resulted in a negligible 1 increase of the total withdrawal time as most of them were immediately discarded by the endoscopists
Detailed Description:
None
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