Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-27 @ 2:34 AM
Study NCT ID:
NCT00828893
Status:
COMPLETED
Last Update Posted:
2012-02-20
First Post:
2009-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Navigation Guidance Gestures Carried Out Under CT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-17', 'studyFirstSubmitDate': '2009-01-23', 'studyFirstSubmitQcDate': '2009-01-23', 'lastUpdatePostDateStruct': {'date': '2012-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum distance between the planned trajectory and trajectory achieved, defined for the needle of local anesthesia.', 'timeFrame': '2 hours'}], 'secondaryOutcomes': [{'measure': 'Maximum distance between the planned trajectory and trajectory achieved by the needle puncture.', 'timeFrame': '2 hours'}, {'measure': 'Duration of intervention', 'timeFrame': '3 hours'}, {'measure': 'Dose irradiation and number of control scanners made', 'timeFrame': '3 hours'}, {'measure': 'overall satisfaction Score', 'timeFrame': '3 hours'}, {'measure': 'Success or failure of the final gesture made', 'timeFrame': '3 hours'}, {'measure': 'Number of attempts', 'timeFrame': '3 hours'}, {'measure': 'number of complications (per-operative, post-surgery)', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['drain under scanner'], 'conditions': ['Drainage', 'Biopsy', 'Punction']}, 'referencesModule': {'references': [{'pmid': '23988636', 'type': 'DERIVED', 'citation': 'Robert AL, Chagnon G, Bricault I, Cinquin P, Moreau-Gaudry A. A generic three-dimensional static force distribution basis for a medical needle inserted into soft tissue. J Mech Behav Biomed Mater. 2013 Dec;28:156-70. doi: 10.1016/j.jmbbm.2013.07.023. Epub 2013 Aug 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the contribution of navigation systems recently developed to guide the punction needle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* more or equal than 18 years old\n* patient affiliated to social security or similarly regime\n* patient sent to hospital for drain under CT\n\nExclusion Criteria:\n\n* Pregnant women and lactating mothers\n* Ward of court or under guardianship\n* Adult unable to express their consent\n* Person deprived of freedom by judicial or administrative decision\n* Person hospitalized without their consent\n* Person under legal protection\n* Person participating in another clinical study'}, 'identificationModule': {'nctId': 'NCT00828893', 'acronym': 'CT-Nav', 'briefTitle': 'Navigation Guidance Gestures Carried Out Under CT', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Interest of the Use of a Navigation Guidance Gestures Carried Out Under CT', 'orgStudyIdInfo': {'id': 'DCIC 08 01'}, 'secondaryIdInfos': [{'id': 'IMACTIS company'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'navigation station', 'type': 'DEVICE', 'description': 'navigation station for gestures (carried out under CT) guidance'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Grenoble', 'country': 'France', 'facility': 'UniversityHospitalGrenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdministrateurCIC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'AdministrateurCIC', 'investigatorAffiliation': 'University Hospital, Grenoble'}}}}