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

Not Applicable

Recruiting

• Conditions: Polyp of Colon; Adenoma Colon; Colorectal Cancer
• Interventions: Diagnostic Test: Computer Aided Detection (CADe)

• Registration Number: NCT05611151
• Lead Sponsor: NEC Corporation

Brief 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.

Study Timeline

• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-08
• Study First Posted: 2022-11-09
• Study Start: 2023-04-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 830

Inclusion Criteria

• Patient is presenting to the endoscopy unit for colon cancer screening or surveillance colonoscopy.
• Signed Informed Consent

Exclusion Criteria

1. Contraindications to colonoscopy
2. Colonoscopy within the previous three (3) years
3. High-risk indications for colonoscopy
4. Antithrombotic therapy that cannot be stopped, precluding polyp resection
5. Inflammatory bowel disease
6. Referred for endoscopic mucosal resection (EMR)
7. Familial adenomatous polyposis syndrome or Serrated Polyposis Syndrome
8. Pregnant or planning a pregnancy during the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HDWL Colonoscopy	Computer Aided Detection (CADe)	HDWL Colonoscopy: Patient undergoes HDWL colonoscopy without CADe
CADe Colonoscopy	Computer Aided Detection (CADe)	CADe Colonoscopy: Patient undergoes WISE VISION® Endoscopy CADe colonoscopy

Primary Outcome Measures

Name	Time	Method
Adenomas per Colonoscopy (APC)	during the procedure/surgery	Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.

Trial Locations

Locations (5)

Humanitas Research Hospital; 🇮🇹 Milan, Italy

Humanitas Mater Domini; 🇮🇹 Castellanza, Italy

Kansas City VA Hospital; 🇺🇸 Kansas City, Missouri, United States

GastroZentrum Lippe; 🇩🇪 Bad Salzuflen, Germany

Portsmouth Hospitals University NHS Trust, Cosham; 🇬🇧 Portsmouth, United Kingdom