Study Stopped
As the study progressed, the intervention became more of a standard of care, thus the study has stalled and been aborted.
The Use of Magnetic Endoscopic Imagers During Colonoscopy for Loop Recognition and Resolution
1 other identifier
observational
800
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 24, 2014
CompletedFirst Posted
Study publicly available on registry
April 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2018
CompletedFebruary 3, 2021
February 1, 2021
4.9 years
February 24, 2014
February 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy of loop recognition by experienced colonoscopists compared to the magnetic imager.
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 Outcomes (1)
Qualitative description of maneuvers used for loop reduction.
within 3 mths
Study Arms (1)
Staff Gastroenterologists.
Staff Gastroenterologists ability to recognize loops will be assessed using an magnetic endoscopic imager.
Interventions
recognizing loop type accuracy of loop type detection methods of loop reduction assessed by type
Eligibility Criteria
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.
You may qualify if:
- adults (18 years and older) undergoing colonoscopy
You may not qualify if:
- age less than 18 years old
- not willing to participate
- cardiac pacemaker
- internal cardiac defibrillator
- previous colonic surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2, Canada
Study Officials
- 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 Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 24, 2014
First Posted
April 10, 2014
Study Start
February 1, 2014
Primary Completion
December 8, 2018
Study Completion
December 8, 2018
Last Updated
February 3, 2021
Record last verified: 2021-02