Endoscopist and Endoscope Motions During Digestive Endoscopy (EndoMouv)

The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements in flexible endoscopy.

Study Overview

• Status: Completed
• Conditions: Scheduled Gastroscopy Under Sedation
• Intervention / Treatment: Procedure: Motions during gastroscopy

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 in flexible endoscopy.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

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 over 18 years old
• Patient who are scheduled for a gastroscopy 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 with an altered upper GI anatomy due to previous surgery
• Patient with a known anomaly of the upper GI anatomy
• 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 gastroscopy; Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for.	Procedure: Motions during gastroscopy; Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for. The endoscope is removed halfway up the esophagus and inserted into the pylorus to the descending duodenum. The gesture is repeated three times.

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 endoscopy
Endoscope motions recording	Endoscope motions recording using the Aurora electromagnetic tracking system (NDI, Waterloo, Canada) inserted in the endoscope operating channel. The Aurora electromagnetic tracking system is designed for tracking tip and orientation of rigid and flexible endoscopes. The system consists of an electromagnetic field generator and a probe carrying the captors.	At time of endoscopy
Endoscope wheels rotation recording	External video recording of the endoscope wheels rotation.	At time of endoscopy
Endoluminal images recording	Endoluminal images recording using the endoscopic camera.	At time of endoscopy

Collaborators and Investigators

• Sponsor: IHU Strasbourg

Publications and helpful links

General Publications

• Kranzfelder M, Wilhelm D, Doundoulakis M, Schneider A, Bauer M, Reiser S, Meining A, Feussner H. A probe-based electromagnetic navigation system to integrate computed tomography during upper gastrointestinal endoscopy. Endoscopy. 2014 Apr;46(4):302-5. doi: 10.1055/s-0033-1358814. Epub 2013 Nov 19.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2018
• Primary Completion (Actual): January 28, 2022
• Study Completion (Actual): January 28, 2022

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 8, 2018

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: Digestive endoscopy; Tracking motion
• Other Study ID Numbers: 17-001; 2017-A01968-45 (Other Identifier: ANSM France)

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