Endoscopist and Endoscope Motions During Colonoscopy

NCT ID: NCT04263818

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-05

Study Completion Date

2021-07-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Intestinal Disease Colonic Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Motions during colonoscopy

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IHU Strasbourg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Silvana PERRETTA, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg

Locations

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Service de Chirurgie Digestive et Endocrinienne, NHC

Strasbourg, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 21409379 (View on PubMed)

Other Identifiers

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19-003

Identifier Type: -

Identifier Source: org_study_id

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