Ignite Creation Date:
2024-05-06 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05141409
Status:
COMPLETED
Last Update Posted:
2022-12-29
First Post:
2021-11-19
Brief Title:
The COMBO CAD Study
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
The COMBO CAD Study Characterization cOMparison Between twO CAD Systems
Status:
COMPLETED
Status Verified Date:
2022-12
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:
COMBO-CAd
Brief Summary:
Implementation of clinical strategies based on optical diagnosis of 5 mm colorectal polyps may lead to a substantial saving of economic and financial resources Despite this 842 of European endoscopists reported not to use such strategies - also named as leave-in situ and resect- and-discard - in their practice due to the fear of an incorrect optical diagnosis
Indeed accuracy of optical diagnosis is operator-dependent and values reported in the community setting are below the safety thresholds proposed for its incorporation in clinical practice
Artificial intelligence AI is being increasingly explored in different domains of medicine particularly those entailing image analysis As optical diagnosis involves subitaneous processing of multiple images searching for specific visual clues and recognizing well-defined visual patterns AI systems has the potential to help endoscopists in distinguish neoplastic from non-neoplastic polyps making the characterization process more reliable and objective Computer-Aided-Diagnosis systems aiming at characterization are called CADx
Preliminary data on CADx showed a high feasibility and accuracy of AI for optical diagnosis of colorectal polyp and initial experiences in clinical practice confirmed preliminary results
To assess the potential benefit and risk of AI-assisted optical diagnosis with standard colonoscopy we exploited two new Computer-Aided-Diagnosis systems CAD-EYE Fujifilm Co and GI-Genius Medtronic that provide the endoscopist with a real-time polyp characterization without the need of optical magnification
Indeed accuracy of optical diagnosis is operator-dependent and values reported in the community setting are below the safety thresholds proposed for its incorporation in clinical practice
Artificial intelligence AI is being increasingly explored in different domains of medicine particularly those entailing image analysis As optical diagnosis involves subitaneous processing of multiple images searching for specific visual clues and recognizing well-defined visual patterns AI systems has the potential to help endoscopists in distinguish neoplastic from non-neoplastic polyps making the characterization process more reliable and objective Computer-Aided-Diagnosis systems aiming at characterization are called CADx
Preliminary data on CADx showed a high feasibility and accuracy of AI for optical diagnosis of colorectal polyp and initial experiences in clinical practice confirmed preliminary results
To assess the potential benefit and risk of AI-assisted optical diagnosis with standard colonoscopy we exploited two new Computer-Aided-Diagnosis systems CAD-EYE Fujifilm Co and GI-Genius Medtronic that provide the endoscopist with a real-time polyp characterization without the need of optical magnification
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