RITUAL Ultivision AI CADe Randomized Controlled Trial

Stopped early · Not applicable

Conditions studied: Colon Adenoma, Polyp of Colon, Adenoma Colon

In brief

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.

Key facts

Study ID

NCT05732233

Run by

Satisfai Health, Inc.

People needed

137

Starts

2023-07-21

Expected to finish

2024-02-23

Last updated by the study team

2024-05-13

Who can join

Age: 45 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 45 to 75 years;
• Screening or surveillance colonoscopy.
• Iinformed consent

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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