NCT05746962

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2022

Completed
8 months until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

March 6, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2024

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

June 30, 2022

Last Update Submit

March 6, 2023

Conditions

Colonic Neoplasms

Keywords

colonoscopyloop formationscopeguide

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (25)

  • loop type

    the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum

  • loop location

    the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum

  • cecal intubation time cecal intubation time and rate

    the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum

  • cecal intubation rate cecal intubation time and rate

    the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum

  • 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

  • +20 more secondary outcomes

Study Arms (2)

Group that does not use the scopeguide screen

ACTIVE COMPARATOR

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

Device: ScopeGuide Navigated Colonoscope

Group using the scopeguide screen

EXPERIMENTAL

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

Device: ScopeGuide Navigated ColonoscopeDevice: Navigation screen

Interventions

ScopeGuide Navigated ColonoscopeDEVICE

colonoscopes equipped with ScopeGuide

Group that does not use the scopeguide screenGroup using the scopeguide screen
Navigation screenDEVICE

ScopeGuide's 3D visualisation screen

Group using the scopeguide screen

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 19-80
  • the patient who visit to examine the colonoscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Han Jo Jeon

Seoul, Seong Buk Gu, 02841, South Korea

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Bora Keum

    borakeum@hanmail.net

    STUDY DIRECTOR

Central Study Contacts

Bora Keum

CONTACT

+82-2-920-6555borakeum@hanmail.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Division of Gastroenterology and Hepatology, Department of Internal Medicine

Study Record Dates

First Submitted

June 30, 2022

First Posted

February 28, 2023

Study Start

March 6, 2023

Primary Completion

August 28, 2023

Study Completion

October 29, 2024

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations

KR(1)