Endoscopist and Endoscope Motions During Digestive Endoscopy

Not Applicable

Completed

• Conditions: Scheduled Gastroscopy Under Sedation
• Interventions: Procedure: Motions during gastroscopy

• Registration Number: NCT03458403
• Lead Sponsor: IHU Strasbourg

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-08
• Study Start: 2018-08-29
• Primary Completion: 2022-01-28
• Study Completion: 2022-01-28
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Motions during gastroscopy	Motions during gastroscopy	Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for.

Primary Outcome Measures

Name	Time	Method
Body motions recording	At time of endoscopy	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 wheels rotation recording	At time of endoscopy	External video recording of the endoscope wheels rotation.
Endoscope motions recording	At time of endoscopy	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.
Endoluminal images recording	At time of endoscopy	Endoluminal images recording using the endoscopic camera.

Trial Locations

Locations (1)

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil; 🇫🇷 Strasbourg, France