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Endoscopist and Endoscope Motions During Digestive Endoscopy (EndoMouv)

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ClinicalTrials.gov Identifier: NCT03458403
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Scheduled Gastroscopy Under Sedation Procedure: Motions during gastroscopy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : August 30, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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.




Primary Outcome Measures :
  1. 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.

  2. 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.


  3. Endoscope wheels rotation recording [ Time Frame: At time of endoscopy ]
    External video recording of the endoscope wheels rotation.

  4. Endoluminal images recording [ Time Frame: At time of endoscopy ]
    Endoluminal images recording using the endoscopic camera.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458403


Contacts
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Contact: Silvana Perretta, MD, PhD + 33 90 11 90 00 silvana.perretta@ircad.fr

Locations
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France
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil Recruiting
Strasbourg, France, 67091
Contact: Silvana Perretta, MD, PhD    +33 88 11 90 00    silvana.perretta@ircad.fr   
Sponsors and Collaborators
IHU Strasbourg
Investigators
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Principal Investigator: Silvana Perretta, MD, PhD Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

Publications:
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Responsible Party: IHU Strasbourg
ClinicalTrials.gov Identifier: NCT03458403     History of Changes
Other Study ID Numbers: 17-001
2017-A01968-45 ( Other Identifier: ANSM France )
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IHU Strasbourg:
Digestive endoscopy
Tracking motion