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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

Patients at a high risk of having neoplastic colorectal polyps include those patients referred to a colonoscopy for a positive FIT, first-degree family history of CRC, personal history of CRC, and history of having had an or adenomatous and serrated lesions in a previous colonoscopy.

indication of undergoing a screening, surveillance, or diagnostic colonoscopy

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 below

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I am at high risk for colorectal polyps due to family history, personal history, or previous findings.

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I am scheduled for a colonoscopy for screening, surveillance, or diagnosis.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

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 more

Trial 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

128,839 Total Patients Enrolled

1 Trials studying Artificial Intelligence

102 Patients Enrolled for Artificial Intelligence

Université de SherbrookeOTHER

292 Previous Clinical Trials

68,643 Total Patients Enrolled

University of British ColumbiaOTHER

1,415 Previous Clinical Trials

2,466,218 Total Patients Enrolled

Media Library

Medtronic-GI genius (Artificial Intelligence) Clinical Trial Eligibility Overview. Trial Name: NCT05244278 — N/A

Artificial Intelligence Research Study Groups: Operating room equipped with the CADe (Medtronic-GI genius for real-time detection), Colonoscopy performed in room without CADe system

Artificial Intelligence Clinical Trial 2023: Medtronic-GI genius Highlights & Side Effects. Trial Name: NCT05244278 — N/A

Medtronic-GI genius (Artificial Intelligence) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05244278 — N/A

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

Recent research and studies

clinicaltrials.govStudy

Artificial Intelligence (AI) Assisted Real-time Adenoma Detection During Colonoscopies

2023. "Artificial Intelligence (AI) Assisted Real-time Adenoma Detection During Colonoscopies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05244278.