NCT05611151

Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy

Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy: Prospective, Randomized Clinical Performance Evaluation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 830 (actual)
• Sponsor: NEC Corporation · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized study to evaluate the clinical performance of a novel CADe device, WISE VISION® Endoscopy System, in patients undergoing high-definition white light (HDWL) colonoscopy for screening or surveillance of colorectal Cancer (CRC). Eligible subjects who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to undergo colonoscopy : * Experimental: CADe colonoscopy procedure with WISE VISION® Endoscopy (CADe Group) * Control: Standard Colonoscopy without CADe (Standard Colonoscopy Group)

Detailed description

This study aims to evaluate whether NEC WISE VISION® Endoscopy enhances the ability to detect mucosal lesions when compared with the current standard-of-care procedure (high-definition white light \[HDWL\] colonoscopy). The CADe device, Wise VISION® Endoscopy, contains an artificial intelligence/machine learning (AI/ML) advanced algorithm to aid the endoscopists in detection of colonic lesions. This study plans to enrol 830 subjects aged ≥ 45 years and \< 75 years, who are scheduled for screening or surveillance colonoscopy. After review of the inclusion and exclusion criteria, eligible subjects will be randomized in a 1:1 ratio to receive either computer-aided colonoscopy (CADe Group) or standard colonoscopy without CADe (Standard Colonoscopy Group). All adenomas, that are identified during the colonoscopies, will be removed and biopsied as per standard clinical practice to assess adenoma miss rate, polyp miss rate, adenomas per colonoscopy and other endpoints.

Conditions

• Colorectal Cancer
• Adenoma Colon
• Polyp of Colon

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Computer Aided Detection (CADe)	Computer-aided detection (CADe) devices are used in conjunction with colonoscopy to aid in the detection of lesions in the gastrointestinal tract.

Timeline

• Start date: 2023-04-30
• Primary completion: 2024-09-10
• Completion: 2024-09-10
• First posted: 2022-11-09
• Last updated: 2024-09-19

Locations

5 sites across 4 countries: United States, Germany, Italy, United Kingdom

Regulatory

• FDA-regulated device study