Ignite Creation Date:
2024-05-06 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03401723
Status:
COMPLETED
Last Update Posted:
2018-04-11
First Post:
2017-12-22
Brief Title:
A Validation Study of a Computerized Movement Analysis of the Colonoscope in Simulated Colonoscopy
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
3D-CoPS
Brief 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 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
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
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 endoscopycolonoscopy 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 oclock 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
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 endoscopycolonoscopy 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 oclock 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None