Efficacy of Magnetic Imaging Colonoscopy Applied to Beginner Endoscopists

Colonic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05746962
• Other study ID #: 2022AN0126
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: October 29, 2024

Study information

• Verified date: March 2023
• Source: Korea University Anam Hospital
• Contact: Bora Keum
• Phone: +82-2-920-6555
• Email: borakeum[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: October 29, 2024
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

Device:
• ScopeGuide Navigated Colonoscope
colonoscopes equipped with ScopeGuide
• Navigation screen
ScopeGuide's 3D visualisation screen

Locations

Country	Name	City	State
Korea, Republic of	Han Jo Jeon	Seoul	Seong Buk Gu

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	loop type	loop type	the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
Secondary	loop location	loop location	the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	loop removal	success or failure of loop removal	during colonoscope insertion and after cecum arrival of colonoscope
Secondary	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
Secondary	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
Secondary	withdrawal time	withdrawal time (=examination time - cecal intubation time)	the time during withdrawal of the colonoscope towards the anus
Secondary	polyp detection rate	polyp detection rate	during whole colonoscopy examination
Secondary	adenoma detection rate	adenoma detection rate	during whole colonoscopy examination
Secondary	total sedation dose	total sedation dose during colonoscopy	during whole colonoscopy examination
Secondary	length of total inserted colonoscope	length of total inserted colonoscope	after arrival at the cecum
Secondary	application of pressure	nurse assissted abdominal pressure	the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
Secondary	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
Secondary	variance of blood pressure	variance of blood pressure	during whole colonoscopy examination
Secondary	variance of heart rate	variance of heart rate	during whole colonoscopy examination
Secondary	variance of respiration rate	variance of respiration rate	during whole colonoscopy examination
Secondary	variance of saturated oxygenation rate	variance of saturated oxygenation rate	during whole colonoscopy examination
Secondary	adverse events	bleeding, perforation, and mucosal abrasion during colonoscopic exam	during whole colonoscopy examination
Secondary	patients satisfaction (questionnaire)	assessment for pain score through the examination	during whole colonoscopy examination
Secondary	endoscopists satisfaction (questionnaire)	assessment for maneuverability and difficulty score about insertion through the examination	during whole colonoscopy examination
Secondary	evaluation of risk factors about loop formation	factors that make a colonoscope loop	during whole colonoscopy examination