Completed

NCT Number: NCT03458403

Endoscopist and Endoscope Motions During Digestive Endoscopy

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

Completed

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Key information

Conditions

Scheduled Gastroscopy Under Sedation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Strasbourg, 67091, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motions during gastroscopy

Procedure

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.

Primary outcomes

Body motions recording

Time frame: 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 motions recording

Time frame: 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.
Endoscope wheels rotation recording

Time frame: At time of endoscopy

External video recording of the endoscope wheels rotation.
Endoluminal images recording

Time frame: At time of endoscopy

Endoluminal images recording using the endoscopic camera.

Sponsors and collaborators

Lead sponsor

IHU Strasbourg

Other

Registry information

Acronym: EndoMouv

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: Mar 8, 2018
Registry last updated: Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.