Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT00828035
Status:
COMPLETED
Last Update Posted:
2012-09-18
First Post:
2009-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Light Endoscopic Robot Use in Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-17', 'studyFirstSubmitDate': '2009-01-22', 'studyFirstSubmitQcDate': '2009-01-22', 'lastUpdatePostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of useful hands, robot as a useful mechanical hand', 'timeFrame': 'one month'}], 'secondaryOutcomes': [{'measure': 'To evaluate reliability and limits of light endoscopic robot : Number of breakdown, failure (manipulation, voice recognition, other )', 'timeFrame': 'one month'}, {'measure': "Compare surgeon's visual comfort in two groups (REL group and AO group) : evaluate scale of surgeon's visual comfort during surgery", 'timeFrame': 'one month'}, {'measure': "Compare surgery's periods", 'timeFrame': 'one month'}, {'measure': 'Evaluate complications : Number of complications (per operative, post operative)', 'timeFrame': 'one month'}, {'measure': 'Evaluate medical and paramedical use of light endoscopic robot : apprentice time, labour time', 'timeFrame': 'one month'}, {'measure': 'Medical and economic evaluation : cost benefit analysis : human cost, cost', 'timeFrame': 'one month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['robotics', 'laparoscopy', 'surgery', 'computer assisted'], 'conditions': ['Laparoscopy']}, 'referencesModule': {'references': [{'pmid': '16526532', 'type': 'BACKGROUND', 'citation': 'Long JA, Descotes JL, Skowron O, Troccaz J, Cinquin P, Boillot B, Terrier N, Rambeaud JJ. [Use of robotics in laparoscopic urological surgery: state of the art]. Prog Urol. 2006 Feb;16(1):3-11. French.'}, {'pmid': '12235507', 'type': 'BACKGROUND', 'citation': 'Aiono S, Gilbert JM, Soin B, Finlay PA, Gordan A. Controlled trial of the introduction of a robotic camera assistant (EndoAssist) for laparoscopic cholecystectomy. Surg Endosc. 2002 Sep;16(9):1267-70. doi: 10.1007/s00464-001-9174-7. Epub 2002 Jun 14.'}, {'pmid': '23477369', 'type': 'DERIVED', 'citation': 'Jarry J, Moreau Gaudry A, Long JA, Chipon E, Cinquin P, Faucheron JL. Miniaturized robotic laparoscope-holder for rectopexy: first results of a prospective study. J Laparoendosc Adv Surg Tech A. 2013 Apr;23(4):351-5. doi: 10.1089/lap.2012.0233. Epub 2013 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'Light Endoscopic Robot evaluation in abdominal and urological laparoscopic surgery : surgery with surgeon and robot (REL group = new treatment) versus surgery with surgeon and assistant (AO group - standard treatment)\n\nPrimary outcome measure : Number of useful hands (light endoscopic robot = one useful mechanical hand)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Laparoscopic surgery indicated\n* Subject with ASA Score 1, 2 or 3\n* Subject with health and social protection\n* 18 years of age or older\n* Written Informed Consent\n\nExclusion Criteria:\n\n* Subject is pregnant or lactating\n* Subject in jail\n* Subject hospitalizes without consent\n* Protected persons aged 18 years or older\n* Subject participated in another study'}, 'identificationModule': {'nctId': 'NCT00828035', 'briefTitle': 'Light Endoscopic Robot Use in Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Light Endoscopic Robot Use in Abdominal and Urological Laparoscopic Surgery', 'orgStudyIdInfo': {'id': 'DCIC 03 39'}, 'secondaryIdInfos': [{'id': 'ENDOCONTROL company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1, REL', 'description': 'rel group : patients with light endoscopic robot', 'interventionNames': ['Procedure: laparoscopic surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2, AO', 'description': 'AO group : Patients with surgery assistant', 'interventionNames': ['Procedure: laparoscopic surgery']}], 'interventions': [{'name': 'laparoscopic surgery', 'type': 'PROCEDURE', 'otherNames': ['robotic laparoscopic surgery', 'robotic abdominal laparoscopic surgery', 'robotic urological laparoscopic surgery'], 'description': 'comparison of two different laparoscopic surgeries : robot versus human', 'armGroupLabels': ['1, REL', '2, AO']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Grenoble', 'state': 'Isère', 'country': 'France', 'facility': 'University Hospital, Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Saint-Étienne-de-Montluc', 'state': 'Pays de la Loire Region', 'country': 'France', 'facility': 'University Hospital, Saint-Etienne', 'geoPoint': {'lat': 47.27622, 'lon': -1.78013}}], 'overallOfficials': [{'name': 'Christian LETOUBLON, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}, {'name': 'Jean-Jacques RAMBEAUD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'AdministrateurCIC', 'investigatorAffiliation': 'University Hospital, Grenoble'}}}}