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

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

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)

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Polyp of Colon; Adenoma Colon
• Intervention / Treatment: Diagnostic test: Computer Aided Detection (CADe)

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 Type: Interventional
• Enrollment (Actual): 830
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Salzuflen, Germany
    • GastroZentrum Lippe
• Italy
  • Castellanza, Italy
    • Humanitas Mater Domini
  • Milan, Italy, 20089
    • Humanitas Research Hospital
• United Kingdom
  • Portsmouth, United Kingdom, PO6 3LY
    • Portsmouth Hospitals University NHS Trust, Cosham
• United States
  • Missouri
    • Kansas City, Missouri, United States, 64128
      • Kansas City VA Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CADe Colonoscopy; CADe Colonoscopy: Patient undergoes WISE VISION® Endoscopy CADe colonoscopy	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.
Active Comparator: HDWL Colonoscopy; HDWL Colonoscopy: Patient undergoes HDWL colonoscopy without CADe	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NEC Corporation
• Collaborators: Meditrial Europe Ltd.; Meditrial USA Inc.
• Investigators: Study Director: Hitoshi Ikeda, NEC Corporation

Publications and helpful links

General Publications

• Yamada M, Saito Y, Imaoka H, Saiko M, Yamada S, Kondo H, Takamaru H, Sakamoto T, Sese J, Kuchiba A, Shibata T, Hamamoto R. Development of a real-time endoscopic image diagnosis support system using deep learning technology in colonoscopy. Sci Rep. 2019 Oct 8;9(1):14465. doi: 10.1038/s41598-019-50567-5.

Helpful Links

• NEC WISE VISION® Endoscopy
• Meditrial Clinical Research Organization

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2023
• Primary Completion (Actual): September 10, 2024
• Study Completion (Actual): September 10, 2024

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 11, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Screening; Artificial Intelligence
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Adenoma; Colonic Polyps
• Other Study ID Numbers: WV-2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No