Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-11

Study Completion Date

2018-04-18

Brief Summary

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This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).

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Detailed Description

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For this study, subjects will be randomized into one of two groups (those who receive a standard colonoscopy and those who receive a colonoscopy with an Endocuff Vision attachment). Results will then be compared between the two; these include insertion time (time it takes to reach the cecum of the large intestine), inspection time (time spent examining the large intestine), the total time per each polypectomy (removal of polyps in the colon), and the total procedure time of the colonoscopy.

Conditions

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Colorectal Polyp Colorectal Adenoma 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 Colonscopy)

Standard colonoscopy with no device attachments

Group Type NO_INTERVENTION

No interventions assigned to this group

Endocuff Vision

Colonoscopy with Endocuff Vision attached to distal end of scope

Group Type EXPERIMENTAL

Endocuff Vision

Intervention Type DEVICE

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

Interventions

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Endocuff Vision

Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision 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

* Subject referred for a screening or surveillance colonoscopy
* Subject is aged 40 years or older
* Subject has the ability to provide informed consent

Exclusion Criteria

* Prior history of colon cancer
* History of inflammatory bowel disease
* Prior surgical resection of any part of the colon
* Use of antiplatelet agents or anticoagulants that precludes the removal of polyps during the procedure
* History of polyposis syndrome or HNPCC
* Family history of colon cancer in a first-degree relative \< 60 years or two first degree relatives with colorectal cancer
* Inability to provide informed consent

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes