Efficacy of Magnetic Imaging Colonoscopy Applied to Beginner Endoscopists

Korea University

Status: Enrolling

Conditions: Colonic Neoplasms

Treatments: Device: Navigation screen; Device: ScopeGuide Navigated Colonoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT05746962

2022AN0126

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

Group that does not use the scopeguide screen

Active Comparator group

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

Treatment:

Device: ScopeGuide Navigated Colonoscope

Group using the scopeguide screen

Experimental group

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

Treatment:

Device: ScopeGuide Navigated Colonoscope

Device: Navigation screen