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

Terminated

• Conditions: Colonoscopic Surgical Procedures
• Interventions: Device: Magnetic endoscopic imager.

• Registration Number: NCT02109536
• Lead Sponsor: Lawrence Charles Hookey

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-04-09
• Study First Posted: 2014-04-10
• Primary Completion: 2018-12-08
• Study Completion: 2018-12-08
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Staff Gastroenterologists.	Magnetic endoscopic imager.	Staff Gastroenterologists ability to recognize loops will be assessed using an magnetic endoscopic imager.

Primary Outcome Measures

Name	Time	Method
Accuracy of loop recognition by experienced colonoscopists compared to the magnetic imager.	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.

Secondary Outcome Measures

Name	Time	Method
Qualitative description of maneuvers used for loop reduction.	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.

Trial Locations

Locations (1)

Hotel Dieu Hospital; 🇨🇦 Kingston, Ontario, Canada