EndoMouv: Endoscopist and Endoscope Motions During Digestive Endoscopy

Sponsor
IHU Strasbourg (Other)
Overall Status
Unknown status
CT.gov ID
NCT03458403
Collaborator
(none)
30
1
1
17.1
1.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Motions during gastroscopy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Endoscopist and Endoscope Motions During Digestive Endoscopy
Actual Study Start Date :
Aug 30, 2018
Anticipated Primary Completion Date :
Feb 1, 2020
Anticipated Study Completion Date :
Feb 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. Endoscope wheels rotation recording [At time of endoscopy]

    External video recording of the endoscope wheels rotation.

  4. Endoluminal images recording [At time of endoscopy]

    Endoluminal images recording using the endoscopic camera.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil Strasbourg France 67091

Sponsors and Collaborators

  • IHU Strasbourg

Investigators

  • Principal Investigator: Silvana Perretta, MD, PhD, Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
IHU Strasbourg
ClinicalTrials.gov Identifier:
NCT03458403
Other Study ID Numbers:
  • 17-001
  • 2017-A01968-45
First Posted:
Mar 8, 2018
Last Update Posted:
Oct 18, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by IHU Strasbourg

Study Results

No Results Posted as of Oct 18, 2019