The Use of Magnetic Endoscopic Imaging for Improving Quality Indicators in Outpatient Colonoscopy

NCT ID: NCT01480830

Last Updated: 2024-08-21

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

633 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-10-31

Brief Summary

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Colonoscopy is an important procedure for diagnosing and treating diseases of the colon. In Canada, up to 13% all colonoscopies do not examine the full colon and are therefore incomplete. Incomplete colonoscopies happen for a number of reasons but are often due to twists and turns in the colon that make the colonoscopy difficult to perform and uncomfortable for the patient.

This randomized study is being done to test a new colonoscopy system called the Scope Guide that shows an exact 3-dimensional picture of how the colonoscopy is positioned in the patient's abdomen.

We hypothesize that the use of the Scope Guide for colonoscopy will improve measures of colonoscopy quality including rate of complete examination, patient comfort, polyp detection rate, insertion time, amount of sedation required, and need for abdominal compression.

Detailed Description

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Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard colonoscopy

Group Type NO_INTERVENTION

No interventions assigned to this group

Magnetic endoscopic imaging colonoscopy

Group Type EXPERIMENTAL

Magnetic Endoscopic Imaging (MEI) colonoscopy

Intervention Type DEVICE

Colonoscopy using the Scope Guide system (Olympus Canada Inc.) by

Interventions

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Magnetic Endoscopic Imaging (MEI) colonoscopy

Colonoscopy using the Scope Guide system (Olympus Canada Inc.) by

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participants must be over the age of 18 presenting for out-patient colonoscopy to the endoscopy unit at the VG Site.

Exclusion Criteria

* Inability or unwillingness to provide written informed consent.
* Previous incomplete or difficult colonoscopy (i.e. independent indication for use of Scope Guide).
* Colonoscopist not participating in trial.
* Current pregnancy.
* Cardiac pacemaker or any other type of implantable stimulator.
* Previous colectomy, hemicolectomy, segmental colon resection, or ileocecal resection.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nova Scotia Health Authority

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald MacIntosh, MD

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Locations

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Capital District Health Authority

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

Other Identifiers

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NCT01480830

Identifier Type: -

Identifier Source: org_study_id

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