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Education3D-CoPSNCT03401723

A Validation Study of a Computerized Movement Analysis of the Colonoscope in Simulated Colonoscopy

A study testing 3D-Colonoscopy Progression Score, Endoscopy Training System and 3D-Colonoscopy Retraction Score in people with Education, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A cross validation study comparing an international acknowledged assessment tool "Endoscopy Training System" (ETS) and movement analysis of the colonoscope based on raw data from coils within the scope. 24 physicians are recruited and divided based on experience (novices and experienced). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Education
What is being tested?
3D-Colonoscopy Progression Score, Endoscopy Training System and 3D-Colonoscopy Retraction Score
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteDenmark
Study dates
1 Dec 2017to 30 Mar 2018
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Physicians

Who cannot join

  • Non physicians

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Copenhagen Acedemy of Medical Education and Simulation

    Copenhagen, 2100

Other trials in Denmark

About this study

Official title: A Validation Study of the 3D-CoPS and 3D-CoRS and Its Relationship With an International Acknowledged Assessment Tool (ETS) in Simulated Colonoscopy

A cross validation study comparing an international acknowledged assessment tool "Endoscopy Training System" (ETS) and movement analysis of the colonoscope based on raw data from coils within the scope.

24 physicians are recruited and divided based on experience (novices and experienced). All participants are to perform twice on the ETS that is based on four tasks; Scope manipulation, tool targeting, loop management and mucosal inspection. The movement of the colonoscope will be gathered during the tasks and correlated to the scores of the ETS.

Read the detailed description

24 physicians are recruited on a voluntarily basis, and will be divided into two groups, based on experience;

  1. 12 Novices (0-50 colonoscopies)
  2. 12 Experienced (> 140 colonoscopies). The groups are to perform twice on the Endoscopy Training System that is based on four tasks; Scope manipulation, tool targeting, loop management and mucosal inspection. Data for 3D-Colonoscopy Retraction Score (3D-CoRS) will be gathered during the task of mucosal inspection and data for 3D-Colonoscopy Progression Score (3D-CoPS) are collected during loop management.

Novice group:

Any physician who has no experience of endoscopies or has done no more than 50 colonoscopies.

Experienced group:

Includes any physician who have succeeded more than 140 colonoscopies. Professional backgrounds include surgeons and gastroenterologists.

Demographic data will gathered from all three groups as follows:

  • Age
  • Sex
  • Speciality
  • Total number of colonoscopies
  • Total number of colonoscopies the last year
  • Time since graduation
  • Experience in simulated endoscopy/colonoscopy The Endoscopy Training System is a simulation system and an assessment tool and includes five different performance metrics and a scoring system. The system is used in combination with an Olympus colonoscope (Olympus Medical Systems Corp. Tokyo, Japan).

Performance metrics:

  1. Scope Manipulation (SM) - The use of torque and tip deflection to move a shape in the colon to the 6 o´clock position and align the same shape within an outline placed upon the monitor screen. Before continuing to the next shape, alignment must be held for 5 seconds.
  2. Tool Targeting (TT) - 10 targets located around the colon must be found. With a biopsy forceps, each target has to been touched for at least 5 seconds before moving to the next target.
  3. Loop Management (LM) - The management of a standard alfa-loop. If during insertion from anus until cecum a loop is formed, it must be first recognised and then unlooped successfully to continue advancing the colonoscope. The Colonoscopy Training Model begin in the left lateral position, but on request, the model can be repositioned in the supine, prone, or right lateral decubitus position. On request, abdominal pressure can be provided when directed by the participant.
  4. Mucosal Inspection (MI) - Randomly placed polyps inside the rubber colon have to be found during withdrawal, requiring inspection and retroflexion in the rectum.
  5. Retroflexion (RF) - 5 targets located around the anus must be found. With a biopsy forcep, each target has to been touched while the colonoscope is retroflexed in the rectum and touched for at least 5 seconds before moving to the next target.

The 3D-Colonoscopy Progression Score (3D-CoPS) and the 3D-Colonoscopy Retraction Score (3D-CoRS) are movement analysis. Electromagnetic coils are built in along the length of the Olympus colonoscopes. They generate a pulsed low-intensity magnetic field that is picked up a receiver coil. The data-points for each coil are inserted into an algorithm for movement analyzing. This analysis is done as a change between the tip of the scope, and the next tracked magnetic coil. The result is a relative movement of the colonoscope in relation to the previous position, and how much the movement is deflected according to the direction the tip points in. This movement analysis is used for distinction between the progression- and retraction phase, and as the basis for the 3D-CoPS and 3D-CoRS analysis, which is essential, such that the 3D-CoRS measurements is performed during withdrawal of the colonoscope.

Conditions
Education
Being tested
3D-Colonoscopy Progression Score, Endoscopy Training System, 3D-Colonoscopy Retraction Score
Keywords
Validation study, Simulation, Endoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D-Colonoscopy Progression ScoreOther

    Also called 3D-CoPS

    3D-Colonoscopy Progression Score is a computerized analysis of the movement of the colonoscope based on data from coils within the colonoscope.

  • Endoscopy Training SystemOther

    Also called ETS

    The Endoscopy Training System is based on the Colonoscopy Training Model platform and includes four different performance metrics and a scoring system.

    1. Scope Manipulation - The use of torque and tip deflection to move a shape in the colon
    2. Tool Targeting - 10 targets located around the colon must be found. With a biopsy forceps, each target has to been touched.
    3. Loop Management - The management of a standard alfa-loop.
    4. Mucosal Inspection - Randomly placed polyps inside the rubber colon have to be found during withdrawal.
  • 3D-Colonoscopy Retraction ScoreOther

    Also called 3D-CoRS

    3D-Colonoscopy Retraction Score is a computerized analysis of the movement of the colonoscope based on data from coils within the colonoscope.

Study groups in NCT03401723
Study groupRoleWhat they receive
NovicesOtherAny physician who has no experience of endoscopies or has done no more than 50 colonoscopies. Each subject included are to perform on the Endoscopy Training System (ETS) during which data for 3D-Colonoscopy Progression Score and 3D-Colonoscopy Retraction Score is gathered.
Receives: Other: 3D-Colonoscopy Progression Score; Other: Endoscopy Training System; Other: 3D-Colonoscopy Retraction Score
ExperiencedOtherIncludes any physician who have succeeded more than 140 colonoscopies. Professional backgrounds include surgeons and gastroenterologists. Each subject included are to perform on the ETS during which data for 3D-Colonoscopy Progression Score and 3D-Colonoscopy Retraction Score is gathered.
Receives: Other: 3D-Colonoscopy Progression Score; Other: Endoscopy Training System; Other: 3D-Colonoscopy Retraction Score

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3D-Colonoscopy Progression Score

    The score is based on a movement analysis of the colonoscope from anus until max insertion(cecum). It is scaled from 0-1000 .A score of zero equals an incomplete procedure and a score of 1 is a very poor score but the cecum was reached. Increasing score represents better technical performance with a maximum score of 1000.

    Measured: 3 months

  2. 3D-Colonoscopy Retraction Score

    The score is based on a movement analysis of the colonoscope from cecum to the anus. It is scaled from 0-1000. A score of zero equals a very poor score, Increasing score represents better technical performance with a maximum score of 1000.

    Measured: 3 months

Secondary outcomes (1)
  1. Relationship to other variables

    Scores from the ETS, 3D-CoPS and 3D-CoRS will be correlated.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2018
  2. Study start1 Dec 2017
  3. Primary completion21 Mar 2018
  4. Study completion30 Mar 2018

Resources

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03401723
Sponsor's protocol ID
3D-CoPS and 3D-CoRS
Acronym
3D-CoPS
Status last verified
Apr 2018
First submitted
22 Dec 2017
Last updated
11 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ritter EM, Cox TC, Trinca KD, Pearl JP. Simulated Colonoscopy Objective Performance Evaluation (SCOPE): a non-computer-based tool for assessment of endoscopic skills. Surg Endosc. 2013 Nov;27(11):4073-80. doi: 10.1007/s00464-013-3063-8. Epub 2013 Jul 17.

    PubMed 23860607
  • Trinca KD, Cox TC, Pearl JP, Ritter EM. Validity evidence for the Simulated Colonoscopy Objective Performance Evaluation scoring system. Am J Surg. 2014 Feb;207(2):218-25. doi: 10.1016/j.amjsurg.2013.08.026. Epub 2013 Oct 23.

    PubMed 24246259

Questions about this trial

What is this clinical trial studying?

A study testing 3D-Colonoscopy Progression Score, Endoscopy Training System and 3D-Colonoscopy Retraction Score in people with Education, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Apr 2018. 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 Denmark. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3D-Colonoscopy Progression Score (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03401723, which also lists 2 linked publications.

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 11 Apr 2018.

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