EndoRings Colonoscopy vs Standard Colonoscopy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

592 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-19

Study Completion Date

2018-09-13

Brief Summary

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

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Detailed Description

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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.

Conditions

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Colorectal Adenoma Colorectal Polyp Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Control Arm (Standard Colonoscopy)

Standard colonoscopy with no device attachment.

Group Type NO_INTERVENTION

No interventions assigned to this group

EndoRings Colonoscopy

Colonoscopy with EndoRings device attached to the distal end of the scope.

Group Type EXPERIMENTAL

EndoRings device

Intervention Type DEVICE

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.

Interventions

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EndoRings device

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes