Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-22 @ 9:54 PM
Study NCT ID:
NCT02267551
Status:
TERMINATED
Last Update Posted:
2016-05-06
First Post:
2014-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-inferiority Study Comparing daVinci Skills Simulator to Mimic dV-Trainer for Preparing Residents to Perform Live Human Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH'}}, 'statusModule': {'whyStopped': 'low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-05', 'studyFirstSubmitDate': '2014-10-14', 'studyFirstSubmitQcDate': '2014-10-16', 'lastUpdatePostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative Time', 'timeFrame': 'at time of supracervical hysterectomy', 'description': 'Operative time will be measured by time elapsed between first grasp of the uterine fundus with the robotic single tooth tenaculum until amputation of the specimen at the internal cervical os.'}], 'secondaryOutcomes': [{'measure': 'Estimated Blood Loss', 'timeFrame': 'during the surgical procedure', 'description': 'As measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume.'}, {'measure': 'Surgical Skill Rating', 'timeFrame': 'following completion of the procedure', 'description': 'As measured by the global assessment tool for evaluation of intraoperative laparoscopic skills (GOALS) tool via video assessment. These ratings will be performed by a group of surgeons who are not involved in the study and are masked as to the identity of the study surgeons.'}, {'measure': 'Continued success with robotic surgery after participation in the study', 'timeFrame': 'during the 12 months following surgical procedure', 'description': 'The number of cases each participating resident performs as primary surgeon the 12 months after completion of the study will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['robotic surgery', 'simulation'], 'conditions': ['Simulation for Preparation of Robotic Surgery']}, 'referencesModule': {'references': [{'pmid': '24368489', 'type': 'BACKGROUND', 'citation': 'Culligan P, Gurshumov E, Lewis C, Priestley J, Komar J, Salamon C. Predictive validity of a training protocol using a robotic surgery simulator. Female Pelvic Med Reconstr Surg. 2014 Jan-Feb;20(1):48-51. doi: 10.1097/SPV.0000000000000045.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine whether a group of resident physicians otherwise naïve to robotic surgery can demonstrate equal levels of proficiency during their first robotic supracervical hysterectomy having received training either with the Mimic dV-Trainer or the daVinci Skills Simulator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obstetrics and gynecology or general surgery residents in ACGME accredited programs naïve to robotic surgery training\n* Completion of the online orientation to daVinci Surgical System\n\nExclusion Criteria:\n\n* Performance of any robotic surgical procedures as the console surgeon\n* Performance of any robotic simulator protocols\n* Any significant amount of time spent on a virtual reality robotic simulator'}, 'identificationModule': {'nctId': 'NCT02267551', 'briefTitle': 'Non-inferiority Study Comparing daVinci Skills Simulator to Mimic dV-Trainer for Preparing Residents to Perform Live Human Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Atlantic Health System'}, 'officialTitle': 'Non-inferiority Study Comparing daVinci Skills Simulator to Mimic dV-Trainer for Preparing Residents to Perform Live Human Surgery', 'orgStudyIdInfo': {'id': '574541-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Mimic dV-Trainer', 'interventionNames': ['Other: Mimic dv-Trainer']}, {'type': 'OTHER', 'label': 'daVinci Skills Simulator', 'interventionNames': ['Other: daVinci Skills Simulator']}], 'interventions': [{'name': 'Mimic dv-Trainer', 'type': 'OTHER', 'armGroupLabels': ['Mimic dV-Trainer']}, {'name': 'daVinci Skills Simulator', 'type': 'OTHER', 'armGroupLabels': ['daVinci Skills Simulator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Morristown Medical Center', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlantic Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}