RITUAL Ultivision AI CADe Randomized Controlled Trial

Satisfai Health, Inc.137 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

137

Conditions

Colon Adenoma Polyp of Colon Adenoma Colon

Interventions

Ultivision AIDEVICE

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.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (4)

UC Irvine

Irvine, California, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Montreal Research Center (CRCHUM)

Montréal (Québec), Montreal, Canada

Humanitas Research Hospital

Milan, Italy

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: During the procedure/surgery

Data from ClinicalTrials.gov

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