RITUAL Ultivision AI CADe Randomized Controlled Trial

Study Overview
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Brief Summary
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Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas). Ultivision AI CADe is indicated for white light colonoscopy only.

Detailed Description
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Ultivision AI contains an image processing software and algorithm based on machine learning technology and convolutional neural networks (CNN). The algorithm's primary function is to identify and highlight the likelihood of the presence of a colon polyp.

Official Title
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Randomized Clinical Trial of the Ultivision AI Artificial Intelligence System for Colorectal Cancer Screening or Surveillance in Colonoscopy

Conditions
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Colon Adenoma, Polyp of Colon, Adenoma Colon

Intervention / Treatment
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* Device: Ultivision AI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 45 to 75 years; Screening or surveillance colonoscopy. Iinformed consent Exclusion Criteria: Colorectal cancer; Inflammatory bowel disease, including Crohn's disease or ulcerative colitis; Polyposis syndrome including Familial Adenomatous Polyposis, Cowden syndome, Linch syndrome, Peutz-Jeghers syndrome, MUITYH associated polyposis, familial Colorectal Cancer type X; Positive Fecal Immunochemical Test; Use anti-platelet agents or anticoagulants that prevent polyps removal; Colon resection, not including the appendix; Subject is pregnant or lactating.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 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: Parallel trial design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultivision AI colonoscopy (CADe Arm)<br>Ultivision AI is used to aid in real-time detection of adenomas. | Device: Ultivision AI<br>* Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas) in adult patients undergoing colorectal cancer screening and surveillance examinations.<br>|
| Active Comparator: Standard colonoscopy (Control Arm)<br>Patients will undergo standard colonoscopy without AI. | Device: Ultivision AI<br>* Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas) in adult patients undergoing colorectal cancer screening and surveillance examinations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma per Colonoscopy (APC) | Superiority of Ultivision-AI arm versus control arm. APC is defined as the total number of histologically confirmed adenomas resected divided by the total number of colonoscopies. | During the procedure/surgery | 
| Adenoma Per Extraction (APE). | Non inferiority of Ultivision-AI arm versus control arm. Where APE is the fraction of adenoma, sessile serrated lesions, and large (>10mm) hyperplastic polyps of the proximal colon (caecum, ascending colon, hepatic flexure, and transverse colon) out of total number of resections. | During the procedure/surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Surveillance, Artificial Intelligence, Colonoscopy