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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01480830
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : December 3, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Colonoscopy Device: Magnetic Endoscopic Imaging (MEI) colonoscopy

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 633 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Magnetic Endoscopic Imaging for Improving Quality Indicators in Outpatient Colonoscopy
Study Start Date : January 2012
Primary Completion Date : September 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Cecal intubation rate [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. Patient comfort [ Time Frame: baseline ]
  2. Amount of sedation required [ Time Frame: baseline ]
  3. Polyp detection rate [ Time Frame: baseline ]
  4. Use of abdominal compression [ Time Frame: baseline ]
  5. Insertion time [ Time Frame: baseline ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01480830


Locations
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 1V7
Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
Principal Investigator: Donald MacIntosh, MD Nova Scotia Health Authority
More Information

Responsible Party: Donald MacIntosh, Physician, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01480830     History of Changes
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: December 2013

Keywords provided by Donald MacIntosh, Capital District Health Authority, Canada:
Quality
indicators