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

Not Applicable

Completed

• Conditions: Colonoscopy
• Interventions: Device: Magnetic Endoscopic Imaging (MEI) colonoscopy

• Registration Number: NCT01480830
• Lead Sponsor: Nova Scotia Health Authority

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-24
• Study First Submitted QC: 2011-11-28
• Study First Posted: 2011-11-29
• Study Start: 2012-01
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 633

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnetic endoscopic imaging colonoscopy	Magnetic Endoscopic Imaging (MEI) colonoscopy	-

Primary Outcome Measures

Name	Time	Method
Cecal intubation rate	baseline

Secondary Outcome Measures

Name	Time	Method
Patient comfort	baseline
Amount of sedation required	baseline
Polyp detection rate	baseline
Use of abdominal compression	baseline
Insertion time	baseline

Trial Locations

Locations (1)

Capital District Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada