Study Results
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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COMPLETED
NA
12 participants
INTERVENTIONAL
2020-06-05
2021-07-05
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
OTHER
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
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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IHU Strasbourg
OTHER
Responsible Party
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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
Countries
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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.
Other Identifiers
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19-003
Identifier Type: -
Identifier Source: org_study_id
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