Endoscopist and Endoscope Motions During Colonoscopy (ScopeGuide)

Étude du Mouvement de l'opérateur et de l'Endoscope au Cours de la Coloscopie

The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements during colonoscopy.

Study Overview

• Status: Completed
• Conditions: Colonic Diseases; Intestinal Disease
• Intervention / Treatment: Procedure: Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67000
    • Service de Chirurgie Digestive et Endocrinienne, NHC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Motions during colonoscopy; Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for

Procedure: Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At time of colonoscopy
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.	At time of colonoscopy
Endoscope wheels rotation recording	External video recording of the endoscope wheels rotation	At time of colonoscopy
Endoluminal images recording	Endoluminal images recording using the endoscopic camera.	At time of colonoscopy

Collaborators and Investigators

• Sponsor: IHU Strasbourg
• Investigators: Principal Investigator: Silvana PERRETTA, MD, PHD, Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg

Publications and helpful links

General Publications

• 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.

Helpful Links

• ScopeGuide-Reference guide

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2020
• Primary Completion (Actual): June 5, 2021
• Study Completion (Actual): July 5, 2021

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: colonoscopy; tracking motion
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colonic Diseases
• Other Study ID Numbers: 19-003

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