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CompletedNCT03458403EndoMouvUpdated Feb 28, 2023

Endoscopist and Endoscope Motions During Digestive Endoscopy

An interventional study of Motions during gastroscopy in Scheduled Gastroscopy Under Sedation, sponsored by IHU Strasbourg. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-28.

Sponsored by IHU Strasbourg · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Scheduled Gastroscopy Under Sedation

Keywords

  • Digestive endoscopy
  • Tracking motion
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Motions during gastroscopy

    Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for.

    Procedure: Motions during gastroscopy

Interventions

  • ProcedureMotions 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At time of endoscopy

  2. 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.

    Time frame: At time of endoscopy

  3. Endoscope wheels rotation recording

    External video recording of the endoscope wheels rotation.

    Time frame: At time of endoscopy

  4. Endoluminal images recording

    Endoluminal images recording using the endoscopic camera.

    Time frame: At time of endoscopy

06

Study locations

1 site
  • Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
    Strasbourg, 67091, France
07

References and documents

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. PubMed 24254384 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03458403
Lead sponsor
IHU Strasbourg
Responsible party
Sponsor
First posted
Mar 8, 2018
Start date
Aug 29, 2018
Primary completion
Jan 28, 2022
Completion
Jan 28, 2022
Last update
Feb 28, 2023

Study contacts

Silvana Perretta, MD, PhD
principal investigator · Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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