Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-31 @ 3:26 AM
Study NCT ID:
NCT01531504
Status:
COMPLETED
Last Update Posted:
2012-12-28
First Post:
2012-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Use of the ViKY Device for Uterus Positioning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-03-27', 'releaseDate': '2014-02-12'}], 'estimatedResultsFirstSubmitDate': '2014-02-12'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-27', 'studyFirstSubmitDate': '2012-01-31', 'studyFirstSubmitQcDate': '2012-02-10', 'lastUpdatePostDateStruct': {'date': '2012-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness', 'timeFrame': '4 months', 'description': 'Number of cases with adequate visualization of pelvic anatomy during endoscopy.'}, {'measure': 'Adverse Events', 'timeFrame': '4 months', 'description': 'Number of perforations during intervention. Number of complications associated with the use of uterine manipulator'}], 'secondaryOutcomes': [{'measure': 'surgery characterization', 'timeFrame': '4 months', 'description': 'Duration of time of each procedure, duration of time to set up Viky UP device'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hysterectomies', 'uterine manipulator'], 'conditions': ['Surgical Procedure, Unspecified']}, 'descriptionModule': {'briefSummary': 'Evaluation of Safety and Efficacy of ViKY Device for Uterus Positioning on 2 US sites', 'detailedDescription': 'The ViKY device "Vision Control for endoscopy" was initially a compact motorized endoscope holder for laparoscopic surgery. It holds the endoscope and is controlled by either a foot pedal or voice activation. It received FDA approval in December 2008 and since that time has been used to facilitate laparoscopic surgery in multiple specialties.\n\nEndoControl now considers using the technology for uterus manipulation in laparoscopic-assisted hysterectomies. Most gynecologic surgeries require displacement of the uterus out of the anatomic location to optimize the surgery. During an abdominal hysterectomy clamps are placed on the uterine cornua allowing easy manipulation of the uterus. The development of laparoscopic surgery required new techniques to manipulate the uterus. Typically a uterine manipulator is placed vaginally and controlled by the surgeon or the surgical assistant during the procedure.\n\nIn conventional operations, the constant physical force decreases the surgical team\'s efficacy and increases fatigue levels. The use of the ViKY device to control the position of the uterus facilitates surgery by enabling the surgeon to maintain a constant "locked" position or by allowing the surgeon to remotely move the uterus at any point of the surgery. The ViKY device also eliminates the need for an extra surgical assistant during laparoscopic-assisted hysterectomies.\n\nThe aim of this study is to collect data to demonstrate safety and effectiveness of the use of the ViKY device for uterine manipulation during conventional laparoscopic-assisted hysterectomies or computer-controlled laparoscopic hysterectomies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80\n* Candidate for conventional laparoscopic-assisted hysterectomies procedures\n* patient has a cervix and a uterus\n\nExclusion criteria\n\n* Difficulty understanding the English language\n* Anatomy that precludes the use of a uterine manipulator\n* Current inclusion in another research study'}, 'identificationModule': {'nctId': 'NCT01531504', 'briefTitle': 'New Use of the ViKY Device for Uterus Positioning', 'organization': {'class': 'INDUSTRY', 'fullName': 'EndoControl'}, 'officialTitle': 'Evaluation of Safety and Effectiveness of ViKY Device for Uterine Positioning', 'orgStudyIdInfo': {'id': 'ViKY UP IDE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Hysterectomy', 'description': 'candidate for a conventional laparoscopic-assisted', 'interventionNames': ['Device: ViKY UP']}], 'interventions': [{'name': 'ViKY UP', 'type': 'DEVICE', 'description': 'laparoscopic-assisted hysterectomy procedure', 'armGroupLabels': ['Hysterectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Arnold ADVINCULA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Floridal Hospital'}, {'name': 'Kevin STEPP, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carolinas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EndoControl', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-02-12', 'type': 'RELEASE'}, {'date': '2014-03-27', 'type': 'RESET'}], 'unpostedResponsibleParty': 'EndoControl'}}}}