Endoscopist and Endoscope Motions During Digestive Endoscopy

Scheduled Gastroscopy Under Sedation Clinical Trial

— EndoMouv  

Official title:

Endoscopist and Endoscope Motions During Digestive Endoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458403
• Other study ID #: 17-001
• Secondary ID: 2017-A01968-45
• Status: Completed
• Phase: N/A
• Start date: August 29, 2018
• Est. completion date: January 28, 2022

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 in flexible endoscopy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 28, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scheduled Gastroscopy Under Sedation

Intervention

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.

Locations

Country	Name	City	State
France	Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
IHU Strasbourg

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — 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 endoscopy
Primary	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
Primary	Endoscope wheels rotation recording	External video recording of the endoscope wheels rotation.	At time of endoscopy
Primary	Endoluminal images recording	Endoluminal images recording using the endoscopic camera.	At time of endoscopy