The Use of Magnetic Endoscopic Imagers During Colonoscopy for Loop Recognition and Resolution

February 1, 2021 updated by: Lawrence Charles Hookey
The purpose of this study is threefold. First, the ability of experienced colonoscopists to recognize the type of loop formed will be assessed and whether the use of the MEI improves this accuracy. Second, to determine which maneuvers are used for loop reduction and whether certain loops have set ways to reduce them. The third component will assess whether the colonoscopist thought that the imager helped or not.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • Hotel Dieu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive male and female patients, 18 years or older, undergoing outpatient colonoscopy in the MEI room at Hotel Dieu Hospital in Kingston, Ontario, Canada will be considered for the study.

Description

Inclusion Criteria:

  • adults (18 years and older) undergoing colonoscopy

Exclusion Criteria:

  • age less than 18 years old
  • not willing to participate
  • cardiac pacemaker
  • internal cardiac defibrillator
  • previous colonic surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Staff Gastroenterologists.
Staff Gastroenterologists ability to recognize loops will be assessed using an magnetic endoscopic imager.
Device: Magnetic endoscopic imager.
recognizing loop type accuracy of loop type detection methods of loop reduction assessed by type

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of loop recognition by experienced colonoscopists compared to the magnetic imager.
Time Frame: within 3 mths
When an endoscopist encounters looping they will verbalize what type of loop they think they have and this will be recorded by the endoscopy nurse on a pre-printed data collection sheet. The magnetic imager will then be turned on and a photo of the imager loop will be saved. A physician not involved with the colonoscopy will compare the image to the endoscopist's answer to determine whether they were correct or incorrect.
within 3 mths

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative description of maneuvers used for loop reduction.
Time Frame: within 3 mths
When an endoscopist encounters looping they will verbalize what type of loop they think they have and what maneuvers (example, reducing with clockwise torque) they used to reduce the loop. The magnetic imager will be turned on and the endoscopist will comment on whether the imager was helpful in reducing the loop. This information will be collected on a pre-printed data collection sheet.
within 3 mths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawrence Charles Hookey

Investigators

  • Principal Investigator: Aman V Arya, MD, Queen's University, GIDRU
  • Principal Investigator: Lawrence Hookey, MD, Queen's University, GIDRU
  • Principal Investigator: Stephen Vanner, MD, Queen's University, GIDRU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

December 8, 2018

Study Completion (Actual)

December 8, 2018

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 10, 2014

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DMED-1639-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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