EndoRings Colonoscopy vs Standard Colonoscopy

Indiana University592 enrolled

Overview

The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope.

This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. This study aims to compare the adenoma detection rates between EndoRings colonoscopy (EC) and Standard colonoscopy (SC). It is assumed that the proportion of patients with at least one adenoma would be 25% with SC and 35% with EC.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

592

Conditions

Colorectal Adenoma Colorectal Polyp Colon Cancer

Interventions

EndoRings deviceDEVICE

Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Screening or Surveillance Colonoscopy * Able to provide written informed consent Exclusion Criteria: * Known narrow colon or colon stenosis * Personal history of Colorectal cancer * History of inflammatory bowel disease * Familial adenomatous polyposis syndrome (FAP) * Hyperplastic polyposis syndrome * Referral for incomplete colonoscopy or polyp clearance

Locations (1)

Indiana University

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Adenoma Detection Rates

Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings.