AI Colorectal Polyp Detection

FujiFilm

Status: Completed

Conditions: Adenoma Colon; Polyp Colorectal

Treatments: Device: EW10-EC02 (Endoscopy Support Program)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04979962

P-21-006

Details and patient eligibility

About

This study is intended to demonstrate the superiority of colorectal polyp detection using computer-assisted colonoscopy compared to conventional colonoscopy.

Enrollment: 1,162 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Average risk subjects undergoing their first colonoscopy (screening) or follow-up colonoscopy for previous history of polyps (surveillance interval of 3 years or greater)
• Patients aged 45 or older
• Patients who can provide an informed consent

Exclusion criteria

• Patients with history of colon resection, Inflammatory Bowel Disease (IBD), Familial Adenomatous Polyposis (FAP), severe comorbidity, including end-stage cardiovascular/pulmonary/liver/renal disease
• Patients who are pregnant or are planning pregnancy during study period
• Patients who are not able to or refuse to give informed consent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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1,162 participants in 2 patient groups

CAC Group

Experimental group

Description:

Inspection with computer assisted colonoscopy.

Treatment:

Device: EW10-EC02 (Endoscopy Support Program)

CC Group

No Intervention group

Description:

Inspection with conventional colonoscopy