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Efficacy of Magnetic Imaging Colonoscopy Applied to Beginner Endoscopists

Primary Purpose

Colonic Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ScopeGuide Navigated Colonoscope
Navigation screen
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colonic Neoplasms focused on measuring colonoscopy, loop formation, scopeguide

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Han Jo JeonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group that does not use the scopeguide screen

Group using the scopeguide screen

Arm Description

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

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

Outcomes

Primary Outcome Measures

proportion of colonoscope loop formation
proportion of colonoscope loop formation

Secondary Outcome Measures

loop type
loop type
loop location
loop location
cecal intubation time cecal intubation time and rate
cecal intubation time
cecal intubation rate cecal intubation time and rate
success rate of cecal intubation
solving time for loop reduction
solving time for loop reduction
trial number of looping during loop reduction
number of loop reduction trial
A method to eliminate the loop of colonoscope
how to solve the looping of colonoscope, ex) clockwise rotation, anti-clockwise rotation
loop removal
success or failure of loop removal
location of loop removal whether loop reduction success and location of loop reduction
the colonic location where loop reduction success
total examination time
total examination time
withdrawal time
withdrawal time (=examination time - cecal intubation time)
polyp detection rate
polyp detection rate
adenoma detection rate
adenoma detection rate
total sedation dose
total sedation dose during colonoscopy
length of total inserted colonoscope
length of total inserted colonoscope
application of pressure
nurse assissted abdominal pressure
patient position change
patient position change during colonoscope insertion
variance of blood pressure
variance of blood pressure
variance of heart rate
variance of heart rate
variance of respiration rate
variance of respiration rate
variance of saturated oxygenation rate
variance of saturated oxygenation rate
adverse events
bleeding, perforation, and mucosal abrasion during colonoscopic exam
patients satisfaction (questionnaire)
assessment for pain score through the examination
endoscopists satisfaction (questionnaire)
assessment for maneuverability and difficulty score about insertion through the examination
evaluation of risk factors about loop formation
factors that make a colonoscope loop

Full Information

First Posted
June 30, 2022
Last Updated
March 6, 2023
Sponsor
Korea University Anam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05746962
Brief Title
Efficacy of Magnetic Imaging Colonoscopy Applied to Beginner Endoscopists
Official Title
Safety and Efficacy of Colonoscopy Magnetic Imaging Device for Beginner Endoscopist: a Prospective Randomized Single-center Single-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
August 28, 2023 (Anticipated)
Study Completion Date
October 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms
Keywords
colonoscopy, loop formation, scopeguide

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group that does not use the scopeguide screen
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group using the scopeguide screen
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
ScopeGuide Navigated Colonoscope
Intervention Description
colonoscopes equipped with ScopeGuide
Intervention Type
Device
Intervention Name(s)
Navigation screen
Intervention Description
ScopeGuide's 3D visualisation screen
Primary Outcome Measure Information:
Title
proportion of colonoscope loop formation
Description
proportion of colonoscope loop formation
Time Frame
the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
Secondary Outcome Measure Information:
Title
loop type
Description
loop type
Time Frame
the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
Title
loop location
Description
loop location
Time Frame
the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
Title
cecal intubation time cecal intubation time and rate
Description
cecal intubation time
Time Frame
the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
Title
cecal intubation rate cecal intubation time and rate
Description
success rate of cecal intubation
Time Frame
the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
Title
solving time for loop reduction
Description
solving time for loop reduction
Time Frame
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
Title
trial number of looping during loop reduction
Description
number of loop reduction trial
Time Frame
during colonoscope insertion, the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
Title
A method to eliminate the loop of colonoscope
Description
how to solve the looping of colonoscope, ex) clockwise rotation, anti-clockwise rotation
Time Frame
during colonoscope insertion, the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
Title
loop removal
Description
success or failure of loop removal
Time Frame
during colonoscope insertion and after cecum arrival of colonoscope
Title
location of loop removal whether loop reduction success and location of loop reduction
Description
the colonic location where loop reduction success
Time Frame
during colonoscope insertion and after cecum arrival of colonoscope
Title
total examination time
Description
total examination time
Time Frame
the time from the insertion of the colonoscope tip into the anal verge until withdrawal of the colonoscope from the cecum towards the anus
Title
withdrawal time
Description
withdrawal time (=examination time - cecal intubation time)
Time Frame
the time during withdrawal of the colonoscope towards the anus
Title
polyp detection rate
Description
polyp detection rate
Time Frame
during whole colonoscopy examination
Title
adenoma detection rate
Description
adenoma detection rate
Time Frame
during whole colonoscopy examination
Title
total sedation dose
Description
total sedation dose during colonoscopy
Time Frame
during whole colonoscopy examination
Title
length of total inserted colonoscope
Description
length of total inserted colonoscope
Time Frame
after arrival at the cecum
Title
application of pressure
Description
nurse assissted abdominal pressure
Time Frame
the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
Title
patient position change
Description
patient position change during colonoscope insertion
Time Frame
the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
Title
variance of blood pressure
Description
variance of blood pressure
Time Frame
during whole colonoscopy examination
Title
variance of heart rate
Description
variance of heart rate
Time Frame
during whole colonoscopy examination
Title
variance of respiration rate
Description
variance of respiration rate
Time Frame
during whole colonoscopy examination
Title
variance of saturated oxygenation rate
Description
variance of saturated oxygenation rate
Time Frame
during whole colonoscopy examination
Title
adverse events
Description
bleeding, perforation, and mucosal abrasion during colonoscopic exam
Time Frame
during whole colonoscopy examination
Title
patients satisfaction (questionnaire)
Description
assessment for pain score through the examination
Time Frame
during whole colonoscopy examination
Title
endoscopists satisfaction (questionnaire)
Description
assessment for maneuverability and difficulty score about insertion through the examination
Time Frame
during whole colonoscopy examination
Title
evaluation of risk factors about loop formation
Description
factors that make a colonoscope loop
Time Frame
during whole colonoscopy examination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bora Keum
Phone
+82-2-920-6555
Email
borakeum@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bora Keum
Organizational Affiliation
borakeum@hanmail.net
Official's Role
Study Director
Facility Information:
Facility Name
Han Jo Jeon
City
Seoul
State/Province
Seong Buk Gu
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Jo Jeon
Phone
+82-2-920-6555
Email
roadstar82@naver.com

12. IPD Sharing Statement

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Efficacy of Magnetic Imaging Colonoscopy Applied to Beginner Endoscopists

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