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

Colorectal Cancer Clinical Trial

— COLOWISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05611151
• Other study ID #: WV-2022-01
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2023
• Est. completion date: January 30, 2025

Study information

• Verified date: March 2024
• Source: NEC Corporation
• Contact: Monica Tocchi, MD, PhD
• Phone: +1 646 933 1025
• Email: m.tocchi[@]meditrial.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 830
• Est. completion date: January 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon
• Colonic Polyps
• Colorectal Cancer
• Polyp of Colon

Intervention

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.

Locations

Country	Name	City	State
Germany	GastroZentrum Lippe	Bad Salzuflen
Italy	Humanitas Mater Domini	Castellanza
Italy	Humanitas Research Hospital	Milan
United Kingdom	Portsmouth Hospitals University NHS Trust, Cosham	Portsmouth
United States	Kansas City VA Hospital	Kansas City	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
NEC Corporation	Meditrial Europe Ltd., Meditrial USA Inc.

Countries where clinical trial is conducted

United States,  Germany,  Italy,  United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenomas per Colonoscopy (APC)	Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.	during the procedure/surgery

External Links

•   Meditrial Clinical Research Organization
•   NEC WISE VISION® Endoscopy