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NCT05732233
Ultivision AI CADe Randomized Controlled Trial
Conditions: Colon Adenoma, Polyp of Colon, Adenoma Colon
Sex: All
Ages: 45 Years – 75 Years
Phase: NA
Enrollment: 1100
Sponsor: Satisfai Health, Inc.
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Age 45 to 75 years;Screening or surveillance colonoscopy.Iinformed consentExclusion 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.
Source: ClinicalTrials.gov (NCT05732233). StuddyBuddy aggregates publicly available trial information.