RITUAL Ultivision AI CADe Randomized Controlled Trial

Not Applicable

Terminated

• Conditions: Colon Adenoma; Polyp of Colon; Adenoma Colon
• Interventions: Device: Ultivision AI

• Registration Number: NCT05732233
• Lead Sponsor: Satisfai Health, Inc.

Brief Summary

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

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.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-07
• Study First Posted: 2023-02-16
• Study Start: 2023-07-21
• Primary Completion: 2024-02-23
• Study Completion: 2024-02-23
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

1. Age 45 to 75 years;
2. Screening or surveillance colonoscopy.
3. Iinformed consent

Exclusion Criteria

1. Colorectal cancer;
2. Inflammatory bowel disease, including Crohn's disease or ulcerative colitis;
3. Polyposis syndrome including Familial Adenomatous Polyposis, Cowden syndome, Linch syndrome, Peutz-Jeghers syndrome, MUITYH associated polyposis, familial Colorectal Cancer type X;
4. Positive Fecal Immunochemical Test;
5. Use anti-platelet agents or anticoagulants that prevent polyps removal;
6. Colon resection, not including the appendix;
7. Subject is pregnant or lactating.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard colonoscopy (Control Arm)	Ultivision AI	Patients will undergo standard colonoscopy without AI.
Ultivision AI colonoscopy (CADe Arm)	Ultivision AI	Ultivision AI is used to aid in real-time detection of adenomas.

Primary Outcome Measures

Name	Time	Method
Adenoma Per Extraction (APE).	During the procedure/surgery	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.
Adenoma per Colonoscopy (APC)	During the procedure/surgery	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.

Trial Locations

Locations (4)

University of Montreal Research Center (CRCHUM); 🇨🇦 Montréal (Québec), Montreal, Canada

Humanitas Research Hospital; 🇮🇹 Milano, Italy

UC Irvine; 🇺🇸 Irvine, California, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States