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Trial Title:
Efficacy of Magnetic Imaging Colonoscopy Applied to Beginner Endoscopists
NCT ID:
NCT05746962
Condition:
Colonic Neoplasms
Conditions: Official terms:
Colonic Neoplasms
Conditions: Keywords:
colonoscopy
loop formation
scopeguide
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
ScopeGuide Navigated Colonoscope
Description:
colonoscopes equipped with ScopeGuide
Arm group label:
Group that does not use the scopeguide screen
Arm group label:
Group using the scopeguide screen
Intervention type:
Device
Intervention name:
Navigation screen
Description:
ScopeGuide's 3D visualisation screen
Arm group label:
Group using the scopeguide screen
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.
Criteria for 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
Gender:
All
Minimum age:
19 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Han Jo Jeon
Address:
City:
Seoul
Zip:
02841
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Han Jo Jeon
Phone:
+82-2-920-6555
Email:
roadstar82@naver.com
Start date:
March 6, 2023
Completion date:
October 29, 2024
Lead sponsor:
Agency:
Korea University Anam Hospital
Agency class:
Other
Source:
Korea University Anam Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05746962
