NCT05414448

Combination of Artificial Intelligence and Mucosal Exposure Device to Enhance Colorectal Neoplasia Detection

Combination of Artificial Intelligence (ENDOAID) and Mucosal Exposure Device (ENDOCUFF) to Enhance Colorectal Neoplasia Detection: a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,726 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The investigators hypothesize that the combined use of CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) would improve the adenoma detection rate when compared to CADe system alone.

Detailed description

High polyp miss rates were reported in standard colonoscopies. As a result, a significant proportion of interval CRC was attributed to the missed lesions during index colonoscopy. Risk factors of missed lesions included proximal location, serrate or flat morphology, poor bowel preparation, short withdrawal time and endoscopist experience. To overcome this pitfall, various methods were developed to improve adenoma detection rate (ADR), including distal attachment devices. Among the mucosal exposure devices, Endocuff Vision® was shown to be superior than conventional colonoscopies. Recently, artificial intelligence and automatic computer-aided polyp detection (CADe) systems have developed rapidly and revolutionized the medical field. Nevertheless, there was a potential limitation of 'blind spot' if the endoscopist failed to expose the colonic mucosa adequately leading to missed lesions. To date, no available data or ongoing clinical trial was reported regarding the combined use of CADe and mucosal exposure devices. It may enhance the performance of CADe and provide a novel definitive solution to this unaddressed yet important clinical problem. In this prospective parallel randomized controlled trial, we aim to evaluate the impact of combined use of a new CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) on colorectal neoplasia detection.

Conditions

• Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

Interventions

Type	Name	Description
DEVICE	ENDOCUFF	ENDOCUFF mucousal exposure device will be used during withdrawal process of the colonoscopy.

Timeline

• Start date: 2023-03-07
• Primary completion: 2025-03-01
• Completion: 2025-12-31
• First posted: 2022-06-10
• Last updated: 2024-05-17

Locations

1 site across 1 country: Hong Kong