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

N

Nova Scotia Health Authority (NSHA)

Status

Completed

Conditions

Colonoscopy

Treatments

Device: Magnetic Endoscopic Imaging (MEI) colonoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT01480830
NCT01480830

Details and patient eligibility

About

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.

Enrollment

633 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

633 participants in 2 patient groups

Standard colonoscopy
No Intervention group
Magnetic endoscopic imaging colonoscopy
Experimental group
Treatment:
Device: Magnetic Endoscopic Imaging (MEI) colonoscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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