NCT05523271

A Multi Center Study Comparing the Efficacy of CAD EYE and the Standard of Care (White Light )

A Multi-center Control Study to Determine the Efficacy of CADEYE in Detecting Colon Polyps in Comparison to Standard of Care

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Theodor Bilharz Research Institute · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study is to assess the sensitivity and added benefits of CADEYE compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.

Detailed description

Failure in polyp recognition is a major determinant for the high rate of missed colorectal neoplasms. In response, technological advances have paved the way for Computer-Aided Polyp Detection (CAD-e) systems. Artificial intelligence systems allow of real-time computer- aided detection of polyps with high-accuracy. CADEYE is a CAD-e system (FUJIFILM) that enables real-time video processing at the same rate as the standard procedure. The data generated from this study will provide an estimate of the ADR throughout the Middle East as well as assess the accuracy of CADEYE in detecting adenomas in comparison to standard of care.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CAD EYE (Computer Aided Diagnosis ----?	CADEYE is a CAD-e system (FUJIFILM) that enables real-time video processing at the same rate as the standard procedure and and allows a real time computer aided detection of polyps with high accuracy.

Timeline

• Start date: 2023-01-16
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2022-08-31
• Last updated: 2023-01-19

Locations

1 site across 1 country: Egypt