Artificial Intelligence (AI) Validation Study for Polyp Detection

Study Overview
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Brief Summary
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Interventional prospective multicenter study: Polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy

Detailed Description
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This is an investigator-initiated multicentre non-randomized prospective interventional trial to validate the performance of a novel state-of-the-art computer-aided diagnostic (CAD) tool in polyp detection implemented as second observer during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy. Patients referred for a screening surveillance or therapeutic colonoscopy will undergo a colonoscopy performed by an endoscopist with moderate to high adenoma detection rate (ADR > 20% and < 50%) while a second observer will follow the procedure on a bedside AI-tool to count the number of detections made by the AI system and categorize the results into positive or negative results as follows (1) true positive, (2) false negative, (3) other positive and (4) obvious false positive. When a doubtful detection is made by the AI-system, the second observer will ask to re-evaluate the indicated region. When the detection is clear, the endoscopist and second observer do not communicate. The entire procedure is recorded.

Official Title
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Artificial Intelligence Validation Trial for Polyp Detection: Pilot Study

Conditions
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Polyp of Colon

Intervention / Treatment
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* Diagnostic Test: Artificial intelligence for polyp detection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years Diagnostic or screening colonoscopy Therapeutic colonoscopy Exclusion Criteria: Inability to give informed consent by the patient or legal representative < 18 years old Any contraindication for colonoscopy or biopsies of the colon Uncontrolled coagulopathy Confirmed diagnosis of inflammatory bowel disease Short bowel or ileostomy Pregnancy

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Colonoscopy with AI | Diagnostic Test: Artificial intelligence for polyp detection<br>* Colonoscopy enriched with artificial intelligence tool developed for polyp detection, implemented as a second observer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of the novel AI system compared to endoscopic diagnosis as gold standard | Determination of the diagnostic accuracy of the novel AI system as second observer | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopist's polyp miss rate as number of extra AI detections | Determination of the AI system's precision and extra value as second observer | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonic polyp, Artificial intelligence, Second observer