Colorectal Polyp Detection Comparing Computer Assisted Colonoscopy With Conventional Colonoscopy

Fujifilm Medical Systems USA, Inc.10 sites in 1 country1,162 target enrollmentNovember 24, 2021

ConditionsPolyp Colorectal Adenoma Colon

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Polyp Colorectal
Sponsor: Fujifilm Medical Systems USA, Inc.
Enrollment: 1162
Locations: 10
Primary Endpoint: Adenoma per colonoscopy (APC)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

November 24, 2021

End Date

November 21, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Fujifilm Medical Systems USA, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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