ScopeGuide: Endoscopist and Endoscope Motions During Colonoscopy

Sponsor
IHU Strasbourg (Other)
Overall Status
Recruiting
CT.gov ID
NCT04263818
Collaborator
(none)
60
1
1
13
4.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for
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 during colonoscopy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Étude du Mouvement de l'opérateur et de l'Endoscope au Cours de la Coloscopie
Actual Study Start Date :
Jun 5, 2020
Anticipated Primary Completion Date :
Jun 5, 2021
Anticipated Study Completion Date :
Jul 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Motions during colonoscopy

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

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

Outcome Measures

Primary Outcome Measures

  1. Body motions recording [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 [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 [At time of colonoscopy]

    External video recording of the endoscope wheels rotation

  4. Endoluminal images recording [At time of colonoscopy]

    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 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service de Chirurgie Digestive et Endocrinienne, NHC Strasbourg France 67000

Sponsors and Collaborators

  • IHU Strasbourg

Investigators

  • Principal Investigator: Silvana PERRETTA, MD, PhD, Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
IHU Strasbourg
ClinicalTrials.gov Identifier:
NCT04263818
Other Study ID Numbers:
  • 19-003
First Posted:
Feb 11, 2020
Last Update Posted:
Feb 10, 2021
Last Verified:
Feb 1, 2021
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2021