NCT04754347

Computer Aided Detection of Polyps in Colonoscopy

Randomized, Controlled Trial of a Computer Aided Detection Device in Standard Colonoscopy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,472 (actual)
• Sponsor: Iterative Scopes, Inc · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the clinical benefit and safety of using a computer aided detection device, Skout, for real-time polyp detection in colonoscopy procedures with the indication of screening or surveillance. One of the reasons for the development of interval colorectal cancers is polyps missed during colonoscopy. Our hypothesis is that with the aid of Skout, the adenomas detected per colonoscopy will increase, and it is plausible to believe that this increase in detection could reduce the incidence of interval cancers.

Conditions

• Colorectal Polyp

Interventions

Type	Name	Description
DEVICE	Computer Aided Detection device	The Computer Aided Detection device, Skout, is designed to help endoscopists detect potential colorectal polyps during colonoscopies. The system performs automated real-time analysis on endoscopic video data to identify potential polyps and produces an informational visual aid around the appropriate sections of the video frames on a display monitor.

Timeline

• Start date: 2021-01-22
• Primary completion: 2021-10-31
• Completion: 2021-10-31
• First posted: 2021-02-15
• Last updated: 2021-12-01

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study