The Use of Magnetic Endoscopic Imaging for Improving Quality Indicators in Outpatient Colonoscopy (SCOPE GUIDE)

August 20, 2024 updated by: Nova Scotia Health Authority

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

633

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Capital District Health Authority

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard colonoscopy
Experimental: Magnetic endoscopic imaging colonoscopy
Device: Magnetic Endoscopic Imaging (MEI) colonoscopy
Colonoscopy using the Scope Guide system (Olympus Canada Inc.) by

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cecal intubation rate
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient comfort
Time Frame: baseline
baseline
Amount of sedation required
Time Frame: baseline
baseline
Polyp detection rate
Time Frame: baseline
baseline
Use of abdominal compression
Time Frame: baseline
baseline
Insertion time
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Investigators

  • Principal Investigator: Donald MacIntosh, MD, Nova Scotia Health Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

November 24, 2011

First Submitted That Met QC Criteria

November 28, 2011

First Posted (Estimated)

November 29, 2011

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NCT01480830

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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