Colonic NeoplasmsNCT05746962
Efficacy of Magnetic Imaging Colonoscopy Applied to Beginner Endoscopists
A study testing ScopeGuide Navigated Colonoscope and Navigation screen in people with Colonic Neoplasms, run by Korea University Anam Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- ScopeGuide Navigated Colonoscope and Navigation screen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Mar 2023to 29 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 19-80
- the patient who visit to examine the colonoscopy
Who cannot join
- 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
Show all 9Show fewer
- who refuse to write the informed consent
- previous history of allergic reaction to sedative drugs and beans, egg
- SBP <80, SpO2<90
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Han Jo Jeon
Seoul, Seong Buk Gu, 02841
Han Jo Jeon, +82-2-920-6555, roadstar82@naver.com
About this study
Official title: Safety and Efficacy of Colonoscopy Magnetic Imaging Device for Beginner Endoscopist: a Prospective Randomized Single-center Single-blind Study
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.
Read the 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.
- Conditions
- Colonic Neoplasms
- Being tested
- ScopeGuide Navigated Colonoscope, Navigation screen
- Keywords
- colonoscopy, loop formation, scopeguide
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScopeGuide Navigated ColonoscopeDevice
colonoscopes equipped with ScopeGuide
Navigation screenDevice
ScopeGuide's 3D visualisation screen
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: ScopeGuide Navigated Colonoscope; Device: Navigation screen |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of colonoscope loop formation
proportion of colonoscope loop formation
Measured: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
Secondary outcomes (25)
loop type
loop type
Measured: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
loop location
loop location
Measured: 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
cecal intubation time
Measured: 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
success rate of cecal intubation
Measured: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
solving time for loop reduction
solving time for loop reduction
Measured: 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
trial number of looping during loop reduction
number of loop reduction trial
Measured: during colonoscope insertion, the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
A method to eliminate the loop of colonoscope
how to solve the looping of colonoscope, ex) clockwise rotation, anti-clockwise rotation
Measured: during colonoscope insertion, the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
loop removal
success or failure of loop removal
Measured: during colonoscope insertion and after cecum arrival of colonoscope
location of loop removal whether loop reduction success and location of loop reduction
the colonic location where loop reduction success
Measured: during colonoscope insertion and after cecum arrival of colonoscope
total examination time
total examination time
Measured: the time from the insertion of the colonoscope tip into the anal verge until withdrawal of the colonoscope from the cecum towards the anus
withdrawal time
withdrawal time (=examination time - cecal intubation time)
Measured: the time during withdrawal of the colonoscope towards the anus
polyp detection rate
polyp detection rate
Measured: during whole colonoscopy examination
adenoma detection rate
adenoma detection rate
Measured: during whole colonoscopy examination
total sedation dose
total sedation dose during colonoscopy
Measured: during whole colonoscopy examination
length of total inserted colonoscope
length of total inserted colonoscope
Measured: after arrival at the cecum
application of pressure
nurse assissted abdominal pressure
Measured: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
patient position change
patient position change during colonoscope insertion
Measured: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
variance of blood pressure
variance of blood pressure
Measured: during whole colonoscopy examination
variance of heart rate
variance of heart rate
Measured: during whole colonoscopy examination
variance of respiration rate
variance of respiration rate
Measured: during whole colonoscopy examination
variance of saturated oxygenation rate
variance of saturated oxygenation rate
Measured: during whole colonoscopy examination
adverse events
bleeding, perforation, and mucosal abrasion during colonoscopic exam
Measured: during whole colonoscopy examination
patients satisfaction (questionnaire)
assessment for pain score through the examination
Measured: during whole colonoscopy examination
endoscopists satisfaction (questionnaire)
assessment for maneuverability and difficulty score about insertion through the examination
Measured: during whole colonoscopy examination
evaluation of risk factors about loop formation
factors that make a colonoscope loop
Measured: during whole colonoscopy examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start6 Mar 2023
- Primary completion28 Aug 2023 (estimated)
- Study completion29 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keum, Bo Ra, Korea University Anam Hospital
- Investigators
- Bora Keum, Study director, borakeum@hanmail.net
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746962
- Sponsor's protocol ID
- 2022AN0126
- Status last verified
- Mar 2023
- First submitted
- 30 Jun 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Colonoscopy Magnetic Imaging Device for Beginner Endoscopist: a Prospective Randomized Single-center Single-blind Study
- ClinicalTrials.gov ID
- NCT05746962
- Acronym / sponsor ID
- 2022AN0126
- Conditions
- Colonic Neoplasms
- Keywords
- colonoscopy, loop formation, scopeguide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 28 Aug 2023 (estimated)
- Study completion
- 29 Oct 2024 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group that does not use the scopeguide screen | Active comparator | Device: ScopeGuide Navigated ColonoscopeThe 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 using the scopeguide screen | Experimental | Device: ScopeGuide Navigated Colonoscope, Device: Navigation screenThe 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 |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 19-80
- the patient who visit to examine the colonoscopy
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScopeGuide Navigated Colonoscopecolonoscopes equipped with ScopeGuide | Device | Group that does not use the scopeguide screen, Group using the scopeguide screen |
| Navigation screenScopeGuide's 3D visualisation screen | Device | Group using the scopeguide screen |
Primary outcome
proportion of colonoscope loop formation
Time frame: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
proportion of colonoscope loop formation
25 secondary outcomes
loop type
Time frame: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
loop location
Time frame: 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
Time frame: 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
Time frame: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
solving time for loop reduction
Time frame: 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
trial number of looping during loop reduction
Time frame: during colonoscope insertion, the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
A method to eliminate the loop of colonoscope
Time frame: during colonoscope insertion, the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
loop removal
Time frame: during colonoscope insertion and after cecum arrival of colonoscope
location of loop removal whether loop reduction success and location of loop reduction
Time frame: during colonoscope insertion and after cecum arrival of colonoscope
total examination time
Time frame: the time from the insertion of the colonoscope tip into the anal verge until withdrawal of the colonoscope from the cecum towards the anus
withdrawal time
Time frame: the time during withdrawal of the colonoscope towards the anus
polyp detection rate
Time frame: during whole colonoscopy examination
adenoma detection rate
Time frame: during whole colonoscopy examination
total sedation dose
Time frame: during whole colonoscopy examination
length of total inserted colonoscope
Time frame: after arrival at the cecum
application of pressure
Time frame: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
patient position change
Time frame: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
variance of blood pressure
Time frame: during whole colonoscopy examination
variance of heart rate
Time frame: during whole colonoscopy examination
variance of respiration rate
Time frame: during whole colonoscopy examination
variance of saturated oxygenation rate
Time frame: during whole colonoscopy examination
adverse events
Time frame: during whole colonoscopy examination
patients satisfaction (questionnaire)
Time frame: during whole colonoscopy examination
endoscopists satisfaction (questionnaire)
Time frame: during whole colonoscopy examination
evaluation of risk factors about loop formation
Time frame: during whole colonoscopy examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bora Keum study director
borakeum@hanmail.net
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ScopeGuide Navigated Colonoscope and Navigation screen in people with Colonic Neoplasms, run by Korea University Anam Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bora Keum (+82-2-920-6555, borakeum@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of colonoscope loop formation (time frame: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.