Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

563 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-13

Study Completion Date

2018-08-07

Brief Summary

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This study evaluates the impact of Endorings™ assisted colonoscopy on the number of polyps detected per patient compared to standard colonoscopy without use of EndoRings™. Half of the participants will receive EndoRings™ assisted colonoscopy, while the other half will receive standard colonoscopy.

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Detailed Description

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Colonoscopy is the gold standard for detection of colorectal neoplasia (polyps and cancers) but it is well known that colonoscopy is associated with a neoplasia miss rate of up to 25%.

One such method of reducing the neoplasia miss rate is cap assisted colonoscopy, where a cap is placed at the distal end of the colonoscope.The theory behind how the cap aids mucosal visualisation is that it depresses and flattens colonic folds, thereby improving visualisation on the proximal sides of folds.

Investigators aim to evaluate the impact of one such cap assisted device: EndoRings™ on polyp detection rates. EndoRings™ has been shown to improve polyp detection rate by 51% compared to 29% for standard colonoscopy in a recent tandem endoscopy study. EndoRings™ has received FDA approval.

Conditions

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Colorectal Neoplasia Intestinal Neoplasms Digestive Neoplasms Digestive System Disease Intestinal Disease Gastrointestinal Disease Gastrointestinal Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard colonoscopy

A standard colonoscope will be used to complete the procedure

Group Type ACTIVE_COMPARATOR

Standard colonoscopy

Intervention Type DEVICE

EndoRings™

An EndoRings™ device will be placed at the distal end of a standard colonoscope

Group Type ACTIVE_COMPARATOR

EndoRings™

Intervention Type DEVICE

Colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope

Interventions

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Standard colonoscopy

Intervention Type DEVICE

EndoRings™

Colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope

Intervention Type DEVICE

Other Intervention Names

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Current standard of care colonoscopy

Eligibility Criteria

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Inclusion Criteria

* Symptomatic patients referred for colonoscopy age ≥ 55.
* Asymptomatic patients age ≥55 undergoing screening or surveillance for polyps and cancers.

Exclusion Criteria

* History of Inflammatory bowel disease
* History of Hereditary non polyposis colorectal cancer (HNPCC)
* Familial adenomatous polyposis syndrome (FAP)
* Hyperplastic polyposis syndrome
* Known colonic stricture

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No