Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-25 @ 4:48 PM
Study NCT ID:
NCT03458403
Status:
COMPLETED
Last Update Posted:
2023-02-28
First Post:
2018-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endoscopist and Endoscope Motions During Digestive Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2018-03-02', 'studyFirstSubmitQcDate': '2018-03-02', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body motions recording', 'timeFrame': 'At time of endoscopy', '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 endoscopy', 'description': 'Endoscope motions recording using the Aurora electromagnetic tracking system (NDI, Waterloo, Canada) inserted in the endoscope operating channel.\n\nThe Aurora electromagnetic tracking system is designed for tracking tip and orientation of rigid and flexible endoscopes. The system consists of an electromagnetic field generator and a probe carrying the captors.'}, {'measure': 'Endoscope wheels rotation recording', 'timeFrame': 'At time of endoscopy', 'description': 'External video recording of the endoscope wheels rotation.'}, {'measure': 'Endoluminal images recording', 'timeFrame': 'At time of endoscopy', 'description': 'Endoluminal images recording using the endoscopic camera.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digestive endoscopy', 'Tracking motion'], 'conditions': ['Scheduled Gastroscopy Under Sedation']}, 'referencesModule': {'references': [{'pmid': '24254384', 'type': 'BACKGROUND', 'citation': 'Kranzfelder M, Wilhelm D, Doundoulakis M, Schneider A, Bauer M, Reiser S, Meining A, Feussner H. A probe-based electromagnetic navigation system to integrate computed tomography during upper gastrointestinal endoscopy. Endoscopy. 2014 Apr;46(4):302-5. doi: 10.1055/s-0033-1358814. Epub 2013 Nov 19.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements in flexible endoscopy.', '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 in flexible endoscopy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient over 18 years old\n* Patient who are scheduled for a gastroscopy 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 with an altered upper GI anatomy due to previous surgery\n* Patient with a known anomaly of the upper GI anatomy\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': 'NCT03458403', 'acronym': 'EndoMouv', 'briefTitle': 'Endoscopist and Endoscope Motions During Digestive Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'IHU Strasbourg'}, 'officialTitle': 'Endoscopist and Endoscope Motions During Digestive Endoscopy', 'orgStudyIdInfo': {'id': '17-001'}, 'secondaryIdInfos': [{'id': '2017-A01968-45', 'type': 'OTHER', 'domain': 'ANSM France'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motions during gastroscopy', 'description': 'Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for.', 'interventionNames': ['Procedure: Motions during gastroscopy']}], 'interventions': [{'name': 'Motions during gastroscopy', 'type': 'PROCEDURE', 'description': 'Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for. The endoscope is removed halfway up the esophagus and inserted into the pylorus to the descending duodenum. The gesture is repeated three times.', 'armGroupLabels': ['Motions during gastroscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Silvana Perretta, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IHU Strasbourg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}