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

Colonoscopy Clinical Trial

— SCOPE GUIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480830
• Other study ID #: NCT12345678
• Status: Completed
• Phase: N/A
• First received: November 24, 2011
• Last updated: December 1, 2013
• Start date: January 2012
• Est. completion date: October 2013

Study information

• Verified date: December 2013
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 633
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Device:
• Magnetic Endoscopic Imaging (MEI) colonoscopy
Colonoscopy using the Scope Guide system (Olympus Canada Inc.) by

Locations

Country	Name	City	State
Canada	Capital District Health Authority	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cecal intubation rate		baseline	No
Secondary	Patient comfort		baseline	No
Secondary	Amount of sedation required		baseline	No
Secondary	Polyp detection rate		baseline	No
Secondary	Use of abdominal compression		baseline	No
Secondary	Insertion time		baseline	No