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

Study Overview
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Brief Summary
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This is a pragmatic, double-blind, randomized, controlled trial, to evaluate the effect of implementing a CADs system within the routine clinical practice of Canadian healthcare institutions. The main hypothesis of this study is that the ADR in the operating room equipped with the GI genius CADe system will be significantly higher than the ADR in the ordinary operating room.

Detailed Description
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This trial will be conducted in four centers across Canada. All patients who meet the in/exclusion criteria can be enrolled. The patient's personal medical history will be reviewed to verify patient inclusion and exclusion criteria (age, history of CRC or adenoma, comorbid conditions, anticoagulation, etc.). Eligible patients will be randomized (1:1) stratified per center in two arms: Intervention arm: patients will be assigned to undergo colonoscopy in a room equipped with the GI genius CAD system. Control arm: patients will undergo colonoscopy in a room not equipped with the GI genius CADe system. The endoscopists performing the colonoscopies will not be involved in the development and implementation of CADe. Additionally, they won't be informed of the ongoing trial and will have the option of not using the CADe when available in the room. This design aims to mitigate operator biases that may be partly responsible for the observed difference between the CADe performance in randomized controlled trials and the CADe performance in implementation studies. Data will be collected on case report forms (CRF), after the procedure, from the clinical files and the endoscopy reports. The data will then be deidentified and transferred to an electronic RedCap database in each institution. A research assistant will collect all information and annotations recorded on the patient's medical file during the procedure. In the treatment group (operating room equipped with the CADe), the Medtronic-GI genius system can be used for real-time support by the endoscopists 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. In the control group (colonoscopy performed in room without CADe system), the participating endoscopists will detect as per standard of care. All colonoscopies (in the intervention and control groups) including polypectomy procedures will be performed at the discretion of the treating physician and per standard of care. All polyps will be resected and sent to the pathology labs of the participating institutions to be evaluated for histology by board-certified pathologists. The histopathology outcomes will be collected and stored in the CRF forms to be used as a reference later.

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

Conditions
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Artificial Intelligence

Intervention / Treatment
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* Device: Medtronic-GI genius (CADe system for detecting colorectal polyps)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indication of undergoing a screening, surveillance, or diagnostic colonoscopy Age 45-89 years Exclusion Criteria: Patients undergoing emergency colonoscopy and patients with a known familial polyposis syndrome or a known inflammatory bowel disease

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: pragmatic double-blinded, randomized, multi-endoscopist, multicenter
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Operating room equipped with the CADe (Medtronic-GI genius for real-time detection)<br>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. | Device: Medtronic-GI genius (CADe system for detecting colorectal polyps)<br>* Medtronic-GI genius: AI will provide real-time feedback throughout each colonoscopy procedure and alert endoscopists to the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen.<br>|
| No Intervention: Colonoscopy performed in room without CADe system<br>In the control group (standard colonoscopy), the participating endoscopists will detect and classify colorectal lesions without using any AI modules. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of colorectal adenomas when using the GI genius platform | To assess whether the GI genius platform can significantly increase the ADR during live colonoscopies, compared to standard colonoscopy among high-risk patients.The ADR is defined as the proportion of patients undergoing GI genius-assisted/standard colonoscopy in whom superior or equal to 1 histopathologically proven adenoma or carcinoma is identified. We will use the histopathology outcomes of the resected polyps as the ground truth to calculate the ADR. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-detection rate by the GI genius system | The probability of an increase in the ADR among the trainees and expert endoscopists when using GI genius AI-assisted colonoscopy compared to standard colonoscopies. | 30 days | 
| Proximal ADR | Proximal ADR is defined as the prevalence of patients with at least 1 adenoma detected proximal to the splenic flexure | 30 days | 
| Sessile serrated lesions (SSL) detection rate | Sessile serrated lesions (SSL) detection rate as the proportion of patients colonoscopy in whom superior or equal to 1 sessile serrated lesion (SSL) is identified | 30 days | 
| Mean number of adenomas per colonoscopy (APC) | Mean number of adenomas per colonoscopy (APC) defined as the total number of adenomas divided by the number of colonoscopies performed | 30 days | 
| Adenomas per positive index colonoscopy (APPC) | Adenomas per positive index colonoscopy (APPC) defined as the total number of adenomas divided by the total of colonoscopies where at least 1 adenoma is detected | 30 days | 
| Sessile serrated lesion per Colonoscopy (SSLPC) | Sessile serrated lesion per Colonoscopy (SSLPC), defined as the total number of histologically confirmed sessile serrated lesions resected divided by the total number of colonoscopies | 30 days | 
| Advanced lesion detection rate (ALDR) | Advanced lesion detection rate (ALDR), defined as the proportion of colonoscopies for which the number of histopathologically proven adenoma >10mm was at least 1. | 30 days | 
| Agreement between the surveillance intervals | To evaluate the agreement between the surveillance intervals based on the optical diagnosis of polyps with the GI genius and the pathology-based recommendation according to the current guidelines. | 30 days | 
| Proportion neoplastic and non-neoplastic polyps | Proportion neoplastic and non-neoplastic polyps (i.e., SSLs, hyperplastic polyps, and high-grade dysplasia and carcinomas (overall and according to size, location, and morphology) | 30 days | 
| CADe utilization rate | CADe utilization rate (when available in the room). Since we can't directly assess the CADe utilization rate without revealing the ongoing trial to the endoscopists, we will rely on two voluntary self-reported measures and a partial objective measure. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyp detection, Adenoma detection, Adenoma per colonoscopy, Sessile serrated lesion detection rate, Sessile serrated lesion per colonoscopy