Endoscopist and Endoscope Motions During Colonoscopy

Colonic Diseases Clinical Trial

— ScopeGuide  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04263818
• Other study ID #: 19-003
• Status: Completed
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: July 5, 2021

Study information

• Verified date: February 2023
• Source: IHU Strasbourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 5, 2021
• Est. primary completion date: June 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Diseases
• Intestinal Disease
• Intestinal Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Service de Chirurgie Digestive et Endocrinienne, NHC	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
IHU Strasbourg

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Endoscope wheels rotation recording	External video recording of the endoscope wheels rotation	At time of colonoscopy
Primary	Endoluminal images recording	Endoluminal images recording using the endoscopic camera.	At time of colonoscopy

External Links

•   ScopeGuide-Reference guide