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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05611151). StuddyBuddy aggregates publicly available trial information.