Colon Cancer Clinical Trial

RITUAL Ultivision AI CADe Randomized Controlled Trial

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Colon Cancer

Estimated Enrollment:

137

Study ID:

NCT05732233

Recruitment Status:

Terminated

Sponsor:

Satisfai Health, Inc.

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There are 3 Locations for this study

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UC Irvine
Irvine California, 92697, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
University of Montreal Research Center (CRCHUM)
Montréal (Québec) Montreal, H2X 0, Canada
Humanitas Research Hospital
Milano , , Italy

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

137

Study ID:

NCT05732233

Recruitment Status:

Terminated

Sponsor:


Satisfai Health, Inc.

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