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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
For polyp size measurement (SCALE-EYE), we will exclude all polyps resected in several pieces (piecemeal resection), or specimens damaged (e.g., fractured) during the suction and retrieval process, submillimeter polyps too small for measurement after resection. Polyps after the 5th resected polyp in a single piece will be excluded to reduce the time associated with the procedure.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, estimation: 3 months
Awards & highlights

Study Summary

This trial is testing whether a computer system can help doctors improve detection and classification of polyps during colonoscopies.

Eligible Conditions
  • Colorectal Adenomas

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, estimation: 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, estimation: 3 months for reporting.

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 more
Other 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

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,289 Total Patients Enrolled
Daniel von RentelnPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
5 Previous Clinical Trials
1,470 Total Patients Enrolled

Media Library

CAD-EYE/SCALE-EYE (Artificial Intelligence) Clinical Trial Eligibility Overview. Trial Name: NCT05236790 — N/A
Colorectal Adenomas Research Study Groups: Artificial intelligence for real-time detection and monitoring of colorectal polyps, Real time polyp detection using a standard colonoscopy without CAD eye
Colorectal Adenomas Clinical Trial 2023: CAD-EYE/SCALE-EYE Highlights & Side Effects. Trial Name: NCT05236790 — N/A
CAD-EYE/SCALE-EYE (Artificial Intelligence) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05236790 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications must applicants fulfill in order to partake in this clinical experiment?

"This AI trial is seeking 348 participants aged 45-80 that plan to undergo a screening, surveillance or diagnostic colonoscopy. Candidates must also provide their signed consent and agreement before the study's commencement."

Answered by AI

Is this trial open to octogenarians?

"To meet the qualifications of this trial, participants must be between 45 to 80 years old. For those under 18 or over 65, there are 3 alternative trials available."

Answered by AI

Is there an opportunity to be a part of this medical experiment at the present time?

"Yes, current information hosted on clinicaltrials.gov corroborates the active recruitment of patients for this medical trial. Originally posted in June 20th 2022, it has since been updated most recently on August 18th 2022 and is admitting 348 individuals at a single location."

Answered by AI

How many participants can be expected to sign up for this research?

"Affirmative. Clinicaltrials.gov confirms that this clinical investigation, initially posted on June 20th 2022, is actively seeking participants. 348 volunteers are needed across a single medical centre to complete the trial."

Answered by AI

Has the FDA sanctioned Detection and classification, as well as size measurement of polyp via Artificial Intelligence (Cad Eye) and Scale Eye?

"Our team at Power believes the safety of Detection and classification and size measurement of polyp by Artificial Intelligence (Cad eye) and Scale Eye to be relatively low, scoring a 1. This is due to it being in Phase 1 with limited data backing safety or efficacy."

Answered by AI
~127 spots leftby Apr 2025