Endoscopist and Endoscope Motions During Colonoscopy (ScopeGuide)
Primary Purpose
Intestinal Disease, Colonic Diseases
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for
Sponsored by
About this trial
This is an interventional other trial for Intestinal Disease focused on measuring colonoscopy, tracking motion
Eligibility Criteria
Inclusion Criteria:
- Patient male or female
- Patient over 18 years old
- Patient who are scheduled for a colonoscopy procedure under sedation
- Patient able to understand the study and provide written informed consent
- Patient affiliated to the French social security system.
Exclusion Criteria:
- Patient unable to provide a written informed consent
- Patient with an altered colonic anatomy due to previous surgery
- Patient with a known anomaly of the colon
- Patient carrying an implantable medical device (pacemaker…)
- Patient with a condition preventing its participation to study procedures, according to investigator's judgment
- Pregnancy or breastfeeding
- Patient in custody
- Patient under guardianship
Sites / Locations
- Service de Chirurgie Digestive et Endocrinienne, NHC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Motions during colonoscopy
Arm Description
Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for
Outcomes
Primary Outcome Measures
Body motions recording
Body motions recording using the "Xsens" tracking device. The "Xsens" motion tracking system consists of 17 wireless motion sensors that are applied with straps to the endoscopist without hindering natural movements.
Endoscope motions recording
Endoscope motions recording using the ScopeGuide tracking system. Real-time visualization of the ScopeGuide system is possible thanks to integrated electromagnetic coils and an external sensor that generate a 3D representation of the colonoscope next to the endoscopic image.
Endoscope wheels rotation recording
External video recording of the endoscope wheels rotation
Endoluminal images recording
Endoluminal images recording using the endoscopic camera.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04263818
Brief Title
Endoscopist and Endoscope Motions During Colonoscopy
Acronym
ScopeGuide
Official Title
Étude du Mouvement de l'opérateur et de l'Endoscope au Cours de la Coloscopie
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 5, 2020 (Actual)
Primary Completion Date
June 5, 2021 (Actual)
Study Completion Date
July 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IHU Strasbourg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements during colonoscopy.
Detailed Description
The increasing development of interventional digestive endoscopy raises the challenge to teach and learn complex endoscopic procedures. Nowadays experts are facing the challenge of explaining precisely an elaborate choreography of movements performed during the procedure, while novices are confronted with a broad range of hand, wrist and shoulder movements each resulting in different endoscope responses. The teaching strategy of endoscopy could benefit from a dedicated motion library that would associate the endoscopist's motion and the consequent endoscope response. A simplified endoscopic language made of individual motions could greatly shorten the learning curve.
The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements during colonoscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Disease, Colonic Diseases
Keywords
colonoscopy, tracking motion
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Motions during colonoscopy
Arm Type
Experimental
Arm Description
Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for
Intervention Type
Procedure
Intervention Name(s)
Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for
Intervention Description
Carrying out the endoscopic procedure planned for the patient with the dedicated colonoscope which has magnetic coils over the entire length of the insertion tube. These magnetic coils generate a pulsed magnetic field at low frequency. These pulses are transmitted to an external receiver, refreshed at 15 images per second, then relayed to the processor to generate a 3D representation of the colonoscope next to it of the endoscopic image. There is no additional risk to the patient compared to current practice.
Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for.
Primary Outcome Measure Information:
Title
Body motions recording
Description
Body motions recording using the "Xsens" tracking device. The "Xsens" motion tracking system consists of 17 wireless motion sensors that are applied with straps to the endoscopist without hindering natural movements.
Time Frame
At time of colonoscopy
Title
Endoscope motions recording
Description
Endoscope motions recording using the ScopeGuide tracking system. Real-time visualization of the ScopeGuide system is possible thanks to integrated electromagnetic coils and an external sensor that generate a 3D representation of the colonoscope next to the endoscopic image.
Time Frame
At time of colonoscopy
Title
Endoscope wheels rotation recording
Description
External video recording of the endoscope wheels rotation
Time Frame
At time of colonoscopy
Title
Endoluminal images recording
Description
Endoluminal images recording using the endoscopic camera.
Time Frame
At time of colonoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient male or female
Patient over 18 years old
Patient who are scheduled for a colonoscopy procedure under sedation
Patient able to understand the study and provide written informed consent
Patient affiliated to the French social security system.
Exclusion Criteria:
Patient unable to provide a written informed consent
Patient with an altered colonic anatomy due to previous surgery
Patient with a known anomaly of the colon
Patient carrying an implantable medical device (pacemaker…)
Patient with a condition preventing its participation to study procedures, according to investigator's judgment
Pregnancy or breastfeeding
Patient in custody
Patient under guardianship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvana PERRETTA, MD, PhD
Organizational Affiliation
Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Chirurgie Digestive et Endocrinienne, NHC
City
Strasbourg
ZIP/Postal Code
67000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21409379
Citation
Kaltenbach T, Leung C, Wu K, Yan K, Friedland S, Soetikno R. Use of the colonoscope training model with the colonoscope 3D imaging probe improved trainee colonoscopy performance: a pilot study. Dig Dis Sci. 2011 May;56(5):1496-502. doi: 10.1007/s10620-011-1614-1. Epub 2011 Mar 16.
Results Reference
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Endoscopist and Endoscope Motions During Colonoscopy
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