Efficacy of Magnetic Imaging Colonoscopy Applied to Beginner Endoscopists

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-06

Study Completion Date

2024-10-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colonic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

ScopeGuide Navigated Colonoscope

Intervention Type DEVICE

colonoscopes equipped with ScopeGuide

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

Group Type EXPERIMENTAL

ScopeGuide Navigated Colonoscope

Intervention Type DEVICE

colonoscopes equipped with ScopeGuide

Navigation screen

Intervention Type DEVICE

ScopeGuide's 3D visualisation screen

Interventions

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ScopeGuide Navigated Colonoscope

colonoscopes equipped with ScopeGuide

Intervention Type DEVICE

Navigation screen

ScopeGuide's 3D visualisation screen

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No