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

Colonoscopic Surgical Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02109536
• Other study ID #: DMED-1639-13
• Status: Terminated
• Start date: February 2014
• Est. completion date: December 8, 2018

Study information

• Verified date: February 2021
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 800
• Est. completion date: December 8, 2018
• Est. primary completion date: December 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopic Surgical Procedures

Intervention

Device:
• Magnetic endoscopic imager.
recognizing loop type accuracy of loop type detection methods of loop reduction assessed by type

Locations

Country	Name	City	State
Canada	Hotel Dieu Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawrence Charles Hookey

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Qualitative description of maneuvers used for loop reduction.	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