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OpenTrials
Completed

NCT Number: NCT01480830

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

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.

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Key information

Conditions

Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capital District Health Authority

Halifax, Nova Scotia, B3H 1V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetic Endoscopic Imaging (MEI) colonoscopy

Device

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

Primary outcomes

  1. Cecal intubation rate

    Time frame: baseline

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Acronym: SCOPE GUIDE

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 29, 2011
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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