NCT05732233

RITUAL Ultivision AI CADe Randomized Controlled Trial

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Satisfai Health, Inc. · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colon Adenoma
• Polyp of Colon
• Adenoma Colon

Interventions

Type	Name	Description
DEVICE	Ultivision 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.

Timeline

• Start date: 2023-07-21
• Primary completion: 2024-02-23
• Completion: 2024-02-23
• First posted: 2023-02-16
• Last updated: 2024-05-13

Locations

4 sites across 3 countries: United States, Canada, Italy

Regulatory

• FDA-regulated device study