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Artificial Intelligence
Detection and classification and size measurement of polyp by Artificial Intelligence (Cad eye) and the Scale Eye for Colorectal Adenomas
N/A
Waitlist Available
Led By Daniel von Renteln
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, estimation: 3 months
Awards & highlights
Summary
This trial is testing whether a computer system can help doctors improve detection and classification of polyps during colonoscopies.
Eligible Conditions
- Colorectal Adenomas
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, estimation: 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, estimation: 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluation of CADe function
Evaluation of the Scale-Eye
Secondary outcome measures
3D scanning assessment
Agreement and discrepancy between SCALE-EYE and other measurement
CADe function: proportion of polyps detected
+6 moreOther outcome measures
A pilot feasibility study using the first 40 recruited patients for determining the best reference for evaluating the SCALE-EYE performance
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Artificial intelligence for real-time detection and monitoring of colorectal polypsExperimental Treatment1 Intervention
Colonoscopies will be performed according to the standard of care. Patients will undergo colonoscopies using CAD-eye (CADe and CADx) and Scale-eye. All optically diagnosed (CADx) polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards. CADx will be combined with human input for final diagnosis.
Group II: Real time polyp detection using a standard colonoscopy without CAD eyeActive Control1 Intervention
Real time polyp detection using a standard colonoscopy without CAD eye and without CADe. Patients will undergo a standard colonoscopy. Polyp size measurement will be assessed visually (phase 1 and 2) or with instruments such as snare or forceps (phase 3 or later) and polyp classification will be done by CADx without further input by the endoscopist. All optically diagnosed polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Detection and classification and size measurement of polyp by Artificial Intelligence (Cad eye) and the Scale Eye
2022
N/A
~350
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Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
370 Previous Clinical Trials
129,467 Total Patients Enrolled
Daniel von RentelnPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
5 Previous Clinical Trials
1,470 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Colonoscopies needed in emergency situations.You have a diagnosed case of inflammatory bowel disease (IBD).You have a medical condition called familial polyposis syndrome.We won't measure polyps that were removed in multiple pieces, damaged during removal, or are too small to measure. Also, we will not measure more than 5 polyps removed at once to reduce the time of the procedure.You currently have an inflamed colon.
Research Study Groups:
This trial has the following groups:- Group 1: Artificial intelligence for real-time detection and monitoring of colorectal polyps
- Group 2: Real time polyp detection using a standard colonoscopy without CAD eye
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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