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

NEC Corporation

Status: Enrolling

Conditions: Polyp of Colon; Adenoma Colon; Colorectal Cancer

Treatments: Diagnostic Test: Computer Aided Detection (CADe)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05611151

WV-2022-01

Details and patient eligibility

About

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)

Full 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.

Enrollment: 830 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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830 participants in 2 patient groups

CADe Colonoscopy

Experimental group

Description:

CADe Colonoscopy: Patient undergoes WISE VISION® Endoscopy CADe colonoscopy

Treatment:

Diagnostic Test: Computer Aided Detection (CADe)

HDWL Colonoscopy

Active Comparator group

Description:

HDWL Colonoscopy: Patient undergoes HDWL colonoscopy without CADe

Treatment:

Diagnostic Test: Computer Aided Detection (CADe)