Summary

Eligibility
for people ages 45-75 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
completion around

Description

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.

Official Title

Randomized Clinical Trial of the Ultivision AI Artificial Intelligence System for Colorectal Cancer Screening or Surveillance in Colonoscopy

Details

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.

Keywords

Colon Adenoma, Polyp of Colon, Adenoma Colon, Screening, Surveillance, Artificial Intelligence, Colonoscopy, Adenoma, Colonic Polyps, Ultivision AI

Eligibility

You can join if…

Open to people ages 45-75

  1. Age 45 to 75 years;
  2. Screening or surveillance colonoscopy.
  3. Iinformed consent

You CAN'T join if...

  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.

Locations

  • 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 0A9 Canada
  • Humanitas Research Hospital
    Milano Italy

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Satisfai Health, Inc.
Links
Satisfai Health Meditrial Clinical Research Organization
ID
NCT05732233
Study Type
Interventional
Participants
Expecting 1100 study participants
Last Updated