A Validation Study of a Computerized Movement Analysis of the Colonoscope in Simulated Colonoscopy (3D-CoPS)

April 10, 2018 updated by: Andreas Slot Vilmann, Rigshospitalet, Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Copenhagen Acedemy of Medical Education and Simulation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Physicians

Exclusion Criteria:

  • Non physicians

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Novices

Any 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.
Other: 3D-Colonoscopy Progression Score
3D-Colonoscopy Progression Score is a computerized analysis of the movement of the colonoscope based on data from coils within the colonoscope.
Other Names:
  • 3D-CoPS
Other: Endoscopy Training System

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.
Other Names:
  • ETS
Other: 3D-Colonoscopy Retraction Score
3D-Colonoscopy Retraction Score is a computerized analysis of the movement of the colonoscope based on data from coils within the colonoscope.
Other Names:
  • 3D-CoRS
Other: Experienced

Includes 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.
Other: 3D-Colonoscopy Progression Score
3D-Colonoscopy Progression Score is a computerized analysis of the movement of the colonoscope based on data from coils within the colonoscope.
Other Names:
  • 3D-CoPS
Other: Endoscopy Training System

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.
Other Names:
  • ETS
Other: 3D-Colonoscopy Retraction Score
3D-Colonoscopy Retraction Score is a computerized analysis of the movement of the colonoscope based on data from coils within the colonoscope.
Other Names:
  • 3D-CoRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3D-Colonoscopy Progression Score
Time Frame: 3 months
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.
3 months
3D-Colonoscopy Retraction Score
Time Frame: 3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship to other variables
Time Frame: 3 months
Scores from the ETS, 3D-CoPS and 3D-CoRS will be correlated.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Technical University of Denmark

Investigators

  • Study Director: Lars Konge, Prof, CAMES-Rigshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

March 21, 2018

Study Completion (Actual)

March 30, 2018

Study Registration Dates

First Submitted

December 22, 2017

First Submitted That Met QC Criteria

January 16, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

April 11, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3D-CoPS and 3D-CoRS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Education

Clinical Trials on 3D-Colonoscopy Progression Score

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe