← Back to all trials
Not Yet Recruiting
NCT05611151
Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy
Conditions: Colorectal Cancer, Adenoma Colon, Polyp of Colon
Sex: All
Ages: 45 Years – 75 Years
Phase: NA
Enrollment: 700
Sponsor: NEC Corporation
Location: Germany
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)
Eligibility Criteria
Inclusion Criteria:Patient is presenting to the endoscopy unit for colon cancer screening or surveillance colonoscopy.Signed Informed ConsentExclusion Criteria:Contraindications to colonoscopyColonoscopy within the previous three (3) yearsHigh-risk indications for colonoscopyAntithrombotic therapy that cannot be stopped, precluding polyp resectionInflammatory bowel diseaseReferred for endoscopic mucosal resection (EMR)Familial adenomatous polyposis syndrome or Serrated Polyposis SyndromePregnant or planning a pregnancy during the study period
Source: ClinicalTrials.gov (NCT05611151). StuddyBuddy aggregates publicly available trial information.