Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06059378
Status:
RECRUITING
Last Update Posted:
2023-10-02
First Post:
2023-09-22
Brief Title:
Real-life Implementation of an AI-based Optical Diagnosis
Sponsor:
Daniel Von Renteln
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
Real-life Implementation of an Artificial Intelligence Based Optical Diagnosis Strategy for Diminutive Colorectal Polyps
Status:
RECRUITING
Status Verified Date:
2023-09
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:
AI-OD
Brief Summary:
This is a prospective study that is the first to implement resect and discard and diagnose and leave strategies in real-time practice using stringent documentation and adjudication by 2 expert endoscopists as the gold standard Therefore this study mainly aims to evaluate the agreement between CADx assisted optical diagnosis and adjudication by two expert endoscopists in establishing surveillance intervals concordant with the European Society for Gastrointestinal Endoscopy ESGE and US Multisociety task force USMSTF guidelines
Detailed Description:
All patients who meet the inexclusion criteria can be enrolled
Eligible patients will be informed about the study through a consent form that includes information on optical diagnosis resect and discard diagnose and leave and AICADx systems Subsequently patients will be asked if they are willing to participate in the study using AI-assisted optical diagnosis and the resect and discard and diagnose and leave strategy If a patient declines to undergo optical diagnosis they will be asked about the reason for their refusal to participate in the study The options for their response include
1 Concerns regarding undergoing an optical diagnosis
2 Reluctance to participate in research projects in general
3 Other reasons
4 Preference not to answer the question This data along with patient characteristics age sex will be captured and kept to analyse reasons for non-participation Patients who agree to participate in the study will undergo standard colonoscopy procedures with AI-assisted optical diagnosis for all diminutive colorectal polyps identified High-definition colonoscopes with a joint computer-assisted classification CADx support CAD-EYE software EW10-EC02 will be used The endoscopists will also use the CAD-EYE blue light imaging BLI mode to enhance the visualization of polyp features During the optical diagnosis using CADx the most probable diagnosis neoplastic or hyperplastic will be displayed on the endoscopy screen If the serrated pathology subtype is determined as the most probable histology the endoscopists will make the final decision They will also indicate whether their optical diagnosis was made with low or high confidence When high-risk histology features are observed using BLI the endoscopists will inform the research assistant for documentation and the polyp will be sent for pathology examination in accordance with the ASGE PIVI guidelines recommendations All polyps 5mm will be send for pathology evaluation as per standard of care Polyp size will be measured using virtual scale technology integrated in the computer-assisted system CAD to ensure an accurate polyp sizing
The surveillance intervals will be determined according to the most recent USMSTF and ESGE guidelines Two independent endoscopists blinded to the initial optical diagnosis will review all video recordings and will independently perform the AI-assisted optical diagnosis for each 1-5mm polyp For polyps 5mm diagnosis will be evaluated through histology as per standard of care
Eligible patients will be informed about the study through a consent form that includes information on optical diagnosis resect and discard diagnose and leave and AICADx systems Subsequently patients will be asked if they are willing to participate in the study using AI-assisted optical diagnosis and the resect and discard and diagnose and leave strategy If a patient declines to undergo optical diagnosis they will be asked about the reason for their refusal to participate in the study The options for their response include
1 Concerns regarding undergoing an optical diagnosis
2 Reluctance to participate in research projects in general
3 Other reasons
4 Preference not to answer the question This data along with patient characteristics age sex will be captured and kept to analyse reasons for non-participation Patients who agree to participate in the study will undergo standard colonoscopy procedures with AI-assisted optical diagnosis for all diminutive colorectal polyps identified High-definition colonoscopes with a joint computer-assisted classification CADx support CAD-EYE software EW10-EC02 will be used The endoscopists will also use the CAD-EYE blue light imaging BLI mode to enhance the visualization of polyp features During the optical diagnosis using CADx the most probable diagnosis neoplastic or hyperplastic will be displayed on the endoscopy screen If the serrated pathology subtype is determined as the most probable histology the endoscopists will make the final decision They will also indicate whether their optical diagnosis was made with low or high confidence When high-risk histology features are observed using BLI the endoscopists will inform the research assistant for documentation and the polyp will be sent for pathology examination in accordance with the ASGE PIVI guidelines recommendations All polyps 5mm will be send for pathology evaluation as per standard of care Polyp size will be measured using virtual scale technology integrated in the computer-assisted system CAD to ensure an accurate polyp sizing
The surveillance intervals will be determined according to the most recent USMSTF and ESGE guidelines Two independent endoscopists blinded to the initial optical diagnosis will review all video recordings and will independently perform the AI-assisted optical diagnosis for each 1-5mm polyp For polyps 5mm diagnosis will be evaluated through histology as per standard of care
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