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Artificial Intelligence
AI-Assisted Detection for Adenoma During Colonoscopy
N/A
Recruiting
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
Age 45-80 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study Summary
This trial will test whether a computer system can help doctors identify colorectal polyps and adenomas during colonoscopies.
Who is the study for?
This trial is for people aged 45-80 who are at high risk of colorectal polyps due to a positive FIT, family or personal history of CRC, or previous polyps. They must consent to the study and need a screening or diagnostic colonoscopy. It's not for those with inflammatory bowel disease, severe coagulopathy, emergency cases, familial polyposis syndrome, or very poor health.Check my eligibility
What is being tested?
The trial tests if using AI (Medtronic-GI genius) during colonoscopies increases adenoma detection rates compared to standard procedures. Participants will be randomly assigned to either an AI-assisted room or a regular one without knowing which they're in (double-blind).See study design
What are the potential side effects?
Since this trial involves non-invasive AI assistance rather than medication, traditional side effects aren't expected. However, there may be risks associated with any differences in procedure outcomes between the two groups.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 45 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Detection rate of colorectal adenomas when using the GI genius platform
Secondary outcome measures
Adenomas per positive index colonoscopy (APPC)
Advanced lesion detection rate (ALDR)
Agreement between the surveillance intervals
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Operating room equipped with the CADe (Medtronic-GI genius for real-time detection)Experimental Treatment1 Intervention
The Medtronic-GI genius (CADe) system can be used to detect polyps of all sizes. Use of CADe is left to the discretion of the treating physician performing the colonoscopy. If used CADe will provide real-time feedback throughout each colonoscopy procedure and will alert the endoscopists of the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen.
Group II: Colonoscopy performed in room without CADe systemActive Control1 Intervention
In the control group (standard colonoscopy), the participating endoscopists will detect and classify colorectal lesions without using any AI modules.
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Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
368 Previous Clinical Trials
128,959 Total Patients Enrolled
1 Trials studying Artificial Intelligence
102 Patients Enrolled for Artificial Intelligence
Université de SherbrookeOTHER
298 Previous Clinical Trials
69,162 Total Patients Enrolled
University of British ColumbiaOTHER
1,419 Previous Clinical Trials
2,466,369 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at high risk for colorectal polyps due to family history, personal history, or previous findings.I do not have inflammatory bowel disease, active colitis, severe coagulopathy, need for emergency colonoscopy, familial polyposis syndrome, or poor general health.I am scheduled for a colonoscopy for screening, surveillance, or diagnosis.I am between 45 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Operating room equipped with the CADe (Medtronic-GI genius for real-time detection)
- Group 2: Colonoscopy performed in room without CADe system
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can adults aged 18 and up participate in the trial?
"For potential participants to qualify, they must be between the ages of 45 and 80."
Answered by AI
Are there any prerequisites for joining this clinical experiment?
"Those hoping to be admitted into this AI trial must have a minimum age of 45 and not exceed 80. A total of 625 participants are currently being sought."
Answered by AI
Is this investigation currently recruiting participants?
"According to the records on clinicaltrials.gov, this medical trial is not taking new participants at the time of writing. It was published on April 1st 2022 and edited lastly on February 19th 2022. Nonetheless, there are 92 other trials looking for enrollees presently."
Answered by AI
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