RITUAL Ultivision AI CADe Randomized Controlled Trial
Megadott ok: Business decision to discontinue the study. Discontinuation is not related to any patient safety or performance issues.
Key facts
- Where
- Irvine és Kansas City, Egyesült ÁllamokSee the 2 sites
Where in Egyesült Államok
- UC IrvineIrvine, Egyesült ÁllamokNo longer taking part
- University of Kansas Medical CenterKansas City, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Satisfai Health, Inc.
- Trial code
- NCT05732233
- Record updated
- 2024. május 13.
- Original description
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).Read full original descriptionShow less
Randomized Clinical Trial of the Ultivision AI Artificial Intelligence System for Colorectal Cancer Screening or Surveillance in Colonoscopy
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.
Inclusion: Age 45 to 75 years; Screening or surveillance colonoscopy; Iinformed consent.
Exclusion: Colon resection, not including the appendix; 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; Use anti-platelet agents or anticoagulants that prevent polyps removal; Positive Fecal Immunochemical Test; Subject is pregnant or lactating.