Colonic Diseases Clinical Trial
— ScopeGuideOfficial title:
Étude du Mouvement de l'opérateur et de l'Endoscope au Cours de la Coloscopie
NCT number | NCT04263818 |
Other study ID # | 19-003 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 5, 2020 |
Est. completion date | July 5, 2021 |
Verified date | February 2023 |
Source | IHU Strasbourg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements during colonoscopy.
Status | Completed |
Enrollment | 12 |
Est. completion date | July 5, 2021 |
Est. primary completion date | June 5, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Service de Chirurgie Digestive et Endocrinienne, NHC | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
IHU Strasbourg |
France,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Endoscope wheels rotation recording | External video recording of the endoscope wheels rotation | At time of colonoscopy | |
Primary | Endoluminal images recording | Endoluminal images recording using the endoscopic camera. | At time of colonoscopy |
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