Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-03-01 @ 12:33 PM
Study NCT ID:
NCT04263818
Status:
COMPLETED
Last Update Posted:
2023-02-28
First Post:
2020-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopist and Endoscope Motions During Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2020-02-07', 'studyFirstSubmitQcDate': '2020-02-07', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body motions recording', 'timeFrame': 'At time of colonoscopy', 'description': '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.'}, {'measure': 'Endoscope motions recording', 'timeFrame': 'At time of colonoscopy', 'description': '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.'}, {'measure': 'Endoscope wheels rotation recording', 'timeFrame': 'At time of colonoscopy', 'description': 'External video recording of the endoscope wheels rotation'}, {'measure': 'Endoluminal images recording', 'timeFrame': 'At time of colonoscopy', 'description': 'Endoluminal images recording using the endoscopic camera.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colonoscopy', 'tracking motion'], 'conditions': ['Intestinal Disease', 'Colonic Diseases']}, 'referencesModule': {'references': [{'pmid': '21409379', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements during colonoscopy.', 'detailedDescription': "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.\n\nThe aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements during colonoscopy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient male or female\n* Patient over 18 years old\n* Patient who are scheduled for a colonoscopy procedure under sedation\n* Patient able to understand the study and provide written informed consent\n* Patient affiliated to the French social security system.\n\nExclusion Criteria:\n\n* Patient unable to provide a written informed consent\n* Patient with an altered colonic anatomy due to previous surgery\n* Patient with a known anomaly of the colon\n* Patient carrying an implantable medical device (pacemaker…)\n* Patient with a condition preventing its participation to study procedures, according to investigator's judgment\n* Pregnancy or breastfeeding\n* Patient in custody\n* Patient under guardianship"}, 'identificationModule': {'nctId': 'NCT04263818', 'acronym': 'ScopeGuide', 'briefTitle': 'Endoscopist and Endoscope Motions During Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'IHU Strasbourg'}, 'officialTitle': "Étude du Mouvement de l'opérateur et de l'Endoscope au Cours de la Coloscopie", 'orgStudyIdInfo': {'id': '19-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motions during colonoscopy', 'description': 'Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for', 'interventionNames': ['Procedure: Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for']}], 'interventions': [{'name': 'Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for', 'type': 'PROCEDURE', 'description': '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.\n\nRecording of endoscopist and endoscope motions right after the endoscopic exam the patient came for.', 'armGroupLabels': ['Motions during colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Chirurgie Digestive et Endocrinienne, NHC', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Silvana PERRETTA, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IHU Strasbourg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}