NCT04263818

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

June 5, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2021

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

February 7, 2020

Last Update Submit

February 27, 2023

Conditions

Intestinal DiseaseColonic Diseases

Keywords

colonoscopytracking motion

Outcome Measures

Primary Outcomes (4)

  • 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.

    At time of colonoscopy

  • Endoscope motions recording

    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.

    At time of colonoscopy

  • Endoscope wheels rotation recording

    External video recording of the endoscope wheels rotation

    At time of colonoscopy

  • Endoluminal images recording

    Endoluminal images recording using the endoscopic camera.

    At time of colonoscopy

Study Arms (1)

Motions during colonoscopy

EXPERIMENTAL

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

Interventions

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

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.

Motions during colonoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne, NHC

Strasbourg, 67000, France

Location

Related Publications (1)

  • Kaltenbach T, Leung C, Wu K, Yan K, Friedland S, Soetikno R. Use of the colonoscope training model with the colonoscope 3D imaging probe improved trainee colonoscopy performance: a pilot study. Dig Dis Sci. 2011 May;56(5):1496-502. doi: 10.1007/s10620-011-1614-1. Epub 2011 Mar 16.

    PMID: 21409379BACKGROUND

MeSH Terms

Conditions

Intestinal DiseasesColonic Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Silvana PERRETTA, MD, PhD

    Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 11, 2020

Study Start

June 5, 2020

Primary Completion

June 5, 2021

Study Completion

July 5, 2021

Last Updated

February 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)