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

NCT05611151 | Completed FDA Device

• 1 other identifier: WV-2022-01
• Study Type: interventional
• Target: 830
• Locations: 4 countries
• Sites: 5

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)

Conditions

Colorectal Cancer; Adenoma Colon; Polyp of Colon

Keywords

Screening; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• Adenomas per Colonoscopy (APC)

  Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.

  during the procedure/surgery

Study Arms (2)

CADe Colonoscopy

EXPERIMENTAL

CADe Colonoscopy: Patient undergoes WISE VISION® Endoscopy CADe colonoscopy

Diagnostic Test: Computer Aided Detection (CADe)

HDWL Colonoscopy

ACTIVE COMPARATOR

HDWL Colonoscopy: Patient undergoes HDWL colonoscopy without CADe

Diagnostic Test: Computer Aided Detection (CADe)

Interventions

Computer Aided Detection (CADe) DIAGNOSTIC_TEST

Computer-aided detection (CADe) devices are used in conjunction with colonoscopy to aid in the detection of lesions in the gastrointestinal tract.

CADe Colonoscopy; HDWL Colonoscopy

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• NEC Corporation: lead
• Meditrial Europe Ltd.: collaborator
• Meditrial USA Inc.: collaborator

Study Sites (5)

Kansas City VA Hospital

Kansas City, Missouri, 64128, United States

Location

GastroZentrum Lippe

Bad Salzuflen, Germany

Location

Humanitas Mater Domini

Castellanza, Italy

Location

Humanitas Research Hospital

Milan, 20089, Italy

Location

Portsmouth Hospitals University NHS Trust, Cosham

Portsmouth, PO6 3LY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31594962 BACKGROUND

Related Links

• Meditrial Clinical Research Organization

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Hitoshi Ikeda

  NEC Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel trial design

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 9, 2022
• Study Start: April 30, 2023
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); GB (1); US (1); DE (1)