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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Donald MacIntosh, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01480830
First received: November 24, 2011
Last updated: December 1, 2013
Last verified: December 2013
  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 rate of complete examination, patient comfort, polyp detection rate, insertion time, amount of sedation required, and need for abdominal compression.


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:


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 ]
  • Amount of 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 ]
  • Insertion time [ Time Frame: baseline ] [ Designated as safety issue: No ]

Enrollment: 633
Study Start Date: January 2012
Study Completion Date: October 2013
Primary Completion Date: September 2013 (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.
  • Previous colectomy, hemicolectomy, segmental colon resection, or ileocecal resection.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480830

Locations
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 1V7
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: December 1, 2013
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 16, 2014