Efficacy of Magnetic Imaging Colonoscopy Applied to Beginner Endoscopists

Safety and Efficacy of Colonoscopy Magnetic Imaging Device for Beginner Endoscopist: a Prospective Randomized Single-center Single-blind Study

Magnetic endoscopic imaging (scopeguide) is known to be helpful for colonoscope insertion, especially beginner endoscopist. In this trial, study was designed to show the efficacy and safety pertinent to scopeguide use in detail.

Study Overview

• Status: Recruiting
• Conditions: Colonic Neoplasms
• Intervention / Treatment: Device: ScopeGuide Navigated Colonoscope; Device: Navigation screen

Detailed Description

Colorectal cancer is one of the most commonly diagnosed malignancies worldwide. Colorectal cancer screening significantly reduced the incidence and mortality, and colonoscopy is generally recognized as a standard method. Among them, magnetic endoscopic imaging (MEI, Scopeguide, Magnetic Enhanced Instrument, Olympus, Japan) is a non-radiological imaging instrument that can display the three-dimensional configuration and position of the colonoscope in the abdominal cavity in real time. This study aims to investigate the effectiveness of colonoscopy by measuring the insertion-related index of the colonoscopy according to the scope guide for only beginners of endoscopy.

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bora Keum; Phone Number: +82-2-920-6555; Email: borakeum@hanmail.net

Study Locations

• Korea, Republic of
  • Seong Buk Gu
    • Seoul, Seong Buk Gu, Korea, Republic of, 02841
      • Recruiting
      • Han Jo Jeon
      • Contact: Han Jo Jeon; Phone Number: +82-2-920-6555; Email: roadstar82@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age 19-80
• the patient who visit to examine the colonoscopy

Exclusion Criteria:

• the patient who has a pacemaker
• the patient who has electronic devices in the body
• bowel obstruction and bleeding
• glomerulus filter rate < 30
• inflammatory bowel disease, pregnancy
• previous history of bowel resection and abdominal surgery
• who refuse to write the informed consent
• previous history of allergic reaction to sedative drugs and beans, egg
• SBP <80, SpO2<90

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group that does not use the scopeguide screen; The control group should remove the looping of colonoscope by looking at the general colonoscopy screen The control group cannot use scopeguide screen Scopeguide screen is blinded by an opaque wrapping paper	Device: ScopeGuide Navigated Colonoscope; colonoscopes equipped with ScopeGuide
Experimental: Group using the scopeguide screen; The experimental group uses a general endoscopic image during colonoscopic insertion The experimental group should remove the looping of colonoscope by looking at the scopeguide screen	Device: ScopeGuide Navigated Colonoscope; colonoscopes equipped with ScopeGuide; Device: Navigation screen; ScopeGuide's 3D visualisation screen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of colonoscope loop formation	proportion of colonoscope loop formation	the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
loop type	loop type	the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
loop location	loop location	the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
cecal intubation time cecal intubation time and rate	cecal intubation time	the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
cecal intubation rate cecal intubation time and rate	success rate of cecal intubation	the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
solving time for loop reduction	solving time for loop reduction	during colonoscope insertion, from the time that recognizes the loop and tries to resolve the looping of colonoscope to the time that completely resolved the colonoscope looping
trial number of looping during loop reduction	number of loop reduction trial	during colonoscope insertion, the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
A method to eliminate the loop of colonoscope	how to solve the looping of colonoscope, ex) clockwise rotation, anti-clockwise rotation	during colonoscope insertion, the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
loop removal	success or failure of loop removal	during colonoscope insertion and after cecum arrival of colonoscope
location of loop removal whether loop reduction success and location of loop reduction	the colonic location where loop reduction success	during colonoscope insertion and after cecum arrival of colonoscope
total examination time	total examination time	the time from the insertion of the colonoscope tip into the anal verge until withdrawal of the colonoscope from the cecum towards the anus
withdrawal time	withdrawal time (=examination time - cecal intubation time)	the time during withdrawal of the colonoscope towards the anus
polyp detection rate	polyp detection rate	during whole colonoscopy examination
adenoma detection rate	adenoma detection rate	during whole colonoscopy examination
total sedation dose	total sedation dose during colonoscopy	during whole colonoscopy examination
length of total inserted colonoscope	length of total inserted colonoscope	after arrival at the cecum
application of pressure	nurse assissted abdominal pressure	the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
patient position change	patient position change during colonoscope insertion	the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
variance of blood pressure	variance of blood pressure	during whole colonoscopy examination
variance of heart rate	variance of heart rate	during whole colonoscopy examination
variance of respiration rate	variance of respiration rate	during whole colonoscopy examination
variance of saturated oxygenation rate	variance of saturated oxygenation rate	during whole colonoscopy examination
adverse events	bleeding, perforation, and mucosal abrasion during colonoscopic exam	during whole colonoscopy examination
patients satisfaction (questionnaire)	assessment for pain score through the examination	during whole colonoscopy examination
endoscopists satisfaction (questionnaire)	assessment for maneuverability and difficulty score about insertion through the examination	during whole colonoscopy examination
evaluation of risk factors about loop formation	factors that make a colonoscope loop	during whole colonoscopy examination

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital
• Investigators: Study Director: Bora Keum, borakeum@hanmail.net

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Anticipated): August 28, 2023
• Study Completion (Anticipated): October 29, 2024

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: colonoscopy; loop formation; scopeguide
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 2022AN0126

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No