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

This study is not yet open for participant recruitment.
Verified November 2011 by Capital District Health Authority, Canada
Sponsor:
Information provided by (Responsible Party):
Donald MacIntosh, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01480830
First received: November 24, 2011
Last updated: November 28, 2011
Last verified: November 2011
History of Changes
  Purpose

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 CI rate, patient comfort, polyp detection rate, and the need for additional sedation.


Condition Intervention
Colonoscopy
 Device: Magnetic Endoscopic Imaging (MEI) colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Magnetic Endoscopic Imaging for Improving Quality Indicators in Outpatient Colonoscopy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Cecal intubation rate [ Time Frame: baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient comfort [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Additional sedation required [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Polyp detection rate [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Use of abdominal compression [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Number of times the patient was repositioned [ Time Frame: baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 870
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480830

Contacts
Contact: Donald MacIntosh, MD (902) 473-3620 donald.macintosh@dal.ca

Locations
Canada, Nova Scotia
Capital District Health Authority Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Donald MacIntosh         donald.macintosh@dal.ca    
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: Donald MacIntosh, MD Capital District Health Authority, Canada
  More Information

No publications provided

Responsible Party: Donald MacIntosh, Physician, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01480830     History of Changes
Other Study ID Numbers: NCT12345678
Study First Received: November 24, 2011
Last Updated: November 28, 2011
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 23, 2013