Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy
Completed · Not applicable
Conditions studied: Colorectal Cancer, Adenoma Colon, Polyp of Colon
In brief
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)
Key facts
- Study ID
- NCT05611151
- Run by
- NEC Corporation
- People needed
- 830
- Starts
- 2023-04-30
- Expected to finish
- 2024-09-10
- Last updated by the study team
- 2024-09-19
Who can join
Age: 45 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient is presenting to the endoscopy unit for colon cancer screening or surveillance colonoscopy.
- Signed Informed Consent
You may not qualify if…
- 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
Where it is running
- Kansas City VA Hospital — Kansas City, Missouri, United States
- GastroZentrum Lippe — Bad Salzuflen, Germany
- Humanitas Mater Domini — Castellanza, Italy
- Humanitas Research Hospital — Milan, Italy
- Portsmouth Hospitals University NHS Trust, Cosham — Portsmouth, United Kingdom
Full record on ClinicalTrials.gov
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