Adenoma Colon, Colon Adenoma, Polyp of Colon
Conditions
Keywords
Screening, Surveillance, Artificial Intelligence, Colonoscopy
Brief 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.
Detailed 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.
Interventions
DEVICEUltivision AI
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.
Sponsors
Meditrial USA Inc.
Satisfai Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Pathologist is blind to group assignment
Intervention model description
Parallel trial design
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma per Colonoscopy (APC) | During the procedure/surgery | 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. |
| Adenoma Per Extraction (APE). | During the procedure/surgery | 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. |
Countries
Canada, Italy, United States
Outcome results
None listed