Computer-Aided Detection for Colorectal Cancer
(COLOWISE Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NEC Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?

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)

Research Team

Hitoshi Ikeda

Principal Investigator

NEC Corporation

Eligibility Criteria

This trial is for individuals going to the endoscopy unit for colon cancer screening or surveillance. Participants must sign an informed consent form, indicating they understand and agree to the study's procedures.

Inclusion Criteria

Signed Informed Consent

I am going for a colonoscopy to check for colon cancer.

Exclusion Criteria

Colonoscopy within the previous three (3) years

I have inflammatory bowel disease.

I cannot undergo a colonoscopy due to health risks.

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Treatment Details

Interventions

WISE VISION® Endoscopy System (Computer-Aided Detection)

Trial OverviewThe trial is testing a new Computer Aided Detection (CADe) system called WISE VISION® during colonoscopies. Patients are randomly placed into two groups: one receives a colonoscopy with CADe, while the other undergoes a standard procedure without it.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: CADe ColonoscopyExperimental Treatment1 Intervention

CADe Colonoscopy: Patient undergoes WISE VISION® Endoscopy CADe colonoscopy

Group II: HDWL ColonoscopyActive Control1 Intervention

HDWL Colonoscopy: Patient undergoes HDWL colonoscopy without CADe