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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bad Salzuflen, Germany
- GastroZentrum Lippe
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Castellanza, Italy
- Humanitas Mater Domini
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Milan, Italy, 20089
- HUMANITAS Research Hospital
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Portsmouth, United Kingdom, PO6 3LY
- Portsmouth Hospitals University NHS Trust, Cosham
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Missouri
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Kansas City, Missouri, United States, 64128
- Kansas City VA Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient is presenting to the endoscopy unit for colon cancer screening or surveillance colonoscopy.
- Signed Informed Consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: CADe Colonoscopy
CADe Colonoscopy: Patient undergoes WISE VISION® Endoscopy CADe colonoscopy
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Computer-aided detection (CADe) devices are used in conjunction with colonoscopy to aid in the detection of lesions in the gastrointestinal tract.
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Active Comparator: HDWL Colonoscopy
HDWL Colonoscopy: Patient undergoes HDWL colonoscopy without CADe
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Computer-aided detection (CADe) devices are used in conjunction with colonoscopy to aid in the detection of lesions in the gastrointestinal tract.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Adenomas per Colonoscopy (APC)
Time Frame: during the procedure/surgery
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Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.
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during the procedure/surgery
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hitoshi Ikeda, NEC Corporation
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WV-2022-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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