NCT06116864

Enchasing Polyp Detection: The Effect of Adding Polyp Detection Attachment Device to Computer Aid Detection System.

Enhancing Polyp Detection: A Randomized Controlled Trial Comparing Combined Computer-Aid Detection and Polyp-Detecting Colonoscope Attachment to Computer-Aid Detection Alone in Patients Undergoing Colonoscopy.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,766 (estimated)
• Sponsor: Marshall University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Despite the widespread use of colonoscopy, the ongoing challenge of potentially missing polyps remains. Previous studies have independently shown that both Endocuff, a colonoscope attachment device for polyp detection, and Computer-Aided Detection (CADe) systems have individually demonstrated enhanced lesion detection and safety. This study seeks to evaluate the efficacy of combining the Endocuff CADe versus using CADe alone in colonoscopy procedures for colorectal cancer screening and surveillance. This research project aims to ascertain whether the synergistic application of these technologies yields superior outcomes.

Conditions

• Colon Cancer Screening
• Colon Cancer Surveillance

Interventions

Type	Name	Description
DEVICE	Endocuff and GI Genius	Endocuff is a polyp-detecting colonoscope attachment device. GI Genius is and Computer-Aid Detection (CADe) system to detect polyps
DEVICE	GI Genius	GI Genius is and Computer-Aid Detection (CADe) system to detect polyps

Timeline

• Start date: 2023-10-23
• Primary completion: 2025-04-01
• Completion: 2025-04-15
• First posted: 2023-11-03
• Last updated: 2023-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study