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Completed

NCT Number: NCT04263818

Endoscopist and Endoscope Motions During Colonoscopy

The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements during colonoscopy.

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Key information

Conditions

Intestinal Disease Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Chirurgie Digestive et Endocrinienne, NHC

Strasbourg, 67000, 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 during colonoscopy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient male or female
  • Patient over 18 years old
  • Patient who are scheduled for a colonoscopy 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 unable to provide a written informed consent
  • Patient with an altered colonic anatomy due to previous surgery
  • Patient with a known anomaly of the colon
  • 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

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

Procedure

Carrying out the endoscopic procedure planned for the patient with the dedicated colonoscope which has magnetic coils over the entire length of the insertion tube. These magnetic coils generate a pulsed magnetic field at low frequency. These pulses are transmitted to an external receiver, refreshed at 15 images per second, then relayed to the processor to generate a 3D representation of the colonoscope next to it of the endoscopic image. There is no additional risk to the patient compared to current practice.

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

Primary outcomes

  1. Body motions recording

    Time frame: At time of colonoscopy

    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 colonoscopy

    Endoscope motions recording using the ScopeGuide tracking system. Real-time visualization of the ScopeGuide system is possible thanks to integrated electromagnetic coils and an external sensor that generate a 3D representation of the colonoscope next to the endoscopic image.

  3. Endoscope wheels rotation recording

    Time frame: At time of colonoscopy

    External video recording of the endoscope wheels rotation

  4. Endoluminal images recording

    Time frame: At time of colonoscopy

    Endoluminal images recording using the endoscopic camera.

Sponsors and collaborators

Lead sponsor

IHU Strasbourg

Other

Registry information

Official study title

Étude du Mouvement de l'opérateur et de l'Endoscope au Cours de la Coloscopie

Acronym: ScopeGuide

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 11, 2020
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.

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