An interventional study of Computer Aided Detection (CADe) in Colorectal Cancer, Adenoma Colon and Polyp of Colon, sponsored by NEC Corporation. Completed at 5 sites in 4 countries. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by NEC Corporation · Not applicable, Interventional, and Diagnostic
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 :
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.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's enrollment of 830 is above the median of 250 across 412 interventional studies indexed under Adenoma.
Browse Adenoma studies →This is the only study on the registry with NEC Corporation as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CADe Colonoscopy: Patient undergoes WISE VISION® Endoscopy CADe colonoscopy
Diagnostic Test: Computer Aided Detection (CADe)
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.
Adenomas per Colonoscopy (APC)
Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.
Time frame: during the procedure/surgery
Plan to share: No
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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