Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2026-01-25 @ 4:19 AM
Study NCT ID:
NCT03067532
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2017-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Educational Effect of Home-made Robotic Surgery Simulator for Novice Robotic Surgeons
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-08', 'studyFirstSubmitDate': '2017-02-26', 'studyFirstSubmitQcDate': '2017-02-26', 'lastUpdatePostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparing the understanding and competence level of robotic surgery system', 'timeFrame': 'examination day of study participation', 'description': "questionnaire : please score the difference after finish this study\n\n* understanding about the robotic surgery\n* upskilling of the robotic system drive\n* system's advantages\n\n 1. portable\n 2. anytime possible\n 3. practicality as a real robotic surgery\n 4. understandable of using clutch\n 5. camera management\n\nbetween A and B group system before managing the simulation system and after finishing the simulation system"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Medical School Student', 'Healthy Population']}, 'descriptionModule': {'briefSummary': 'To overcome the obstacles of endoscopic surgery, the da vinci surgical robot system was applied to the various surgery area . And the complete understanding and practice of the robotic system is very important condition for successful robotic surgery.\n\nInvestigator developed a home made robotic surgery simulator for novice robotic surgeons. And investigator want to study about the ability of home made robotic surgery simulator versus existing robotic simulation system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. medical student of Yonsei University College of Medicine\n2. first time of robotic surgery system\n3. voluntary participation of this study\n\nExclusion Criteria:\n\n1. minors \\& foreigner\n2. involuntary participation of this study\n3. refuse to sign a consent form'}, 'identificationModule': {'nctId': 'NCT03067532', 'briefTitle': 'Assessment of Educational Effect of Home-made Robotic Surgery Simulator for Novice Robotic Surgeons', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Assessment of Educational Effect of Home-made Robotic Surgery Simulator for Novice Robotic Surgeons', 'orgStudyIdInfo': {'id': '1-2016-0070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Procedure: existed simulation system user']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Procedure: home made simulator user']}], 'interventions': [{'name': 'existed simulation system user', 'type': 'PROCEDURE', 'description': 'Investigator will divide the subject by the two groups. Each group will take about 15 minutes for exercising drive robotic surgery instrument by each simulation system. After 15 minutes, both group will take an short exam to check the ability to manage the robotic surgery instrument.', 'armGroupLabels': ['A']}, {'name': 'home made simulator user', 'type': 'PROCEDURE', 'description': 'Investigator will divide the subject by the two groups. Each group will take about 15 minutes for exercising drive robotic surgery instrument by each simulation system. After 15 minutes, both group will take an short exam to check the ability to manage the robotic surgery instrument.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Surgery, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}