NCT05963724

Real-Time CAD for Colonic Neoplasia: A RCT

Efficacy of Real-Time Computer Aided-Detected of Colonic Neoplasia in an Underserved Population, A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,100 (actual)
• Sponsor: Riverside University Health System Medical Center · Academic / Other
• Sex: All
• Age: 30 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study assesses the sensitivity and added benefits of computer-aided detection compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.

Detailed description

Failure in polyp detection leads to colon cancer after colonoscopy. Artificial intelligence systems allow real-time computer-aided detection of polyps with high-accuracy. This study will compare GI-Genius, a real-time CAD system to standard colonoscopy in terms of how many colonoscopies detect an adenoma.

Conditions

• Colorectal Cancer
• Colorectal Neoplasms

Interventions

Type	Name	Description
DEVICE	Real-Time Computer Aided Detection	This intervention involves using computer-aided detection using a real-time system (GI-Genius, Medtronic)
PROCEDURE	Stanford Colonoscopy	This involves white-light colonoscopy

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-03-31
• Completion: 2023-05-27
• First posted: 2023-07-27
• Last updated: 2023-07-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study