Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-30 @ 6:41 PM
Study NCT ID:
NCT00802633
Status:
TERMINATED
Last Update Posted:
2014-02-11
First Post:
2008-12-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?
Sponsor:
Organization:
Raw JSON
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'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'whyStopped': 'Enrollment was stopped after eighty patients were enrolled.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-21', 'studyFirstSubmitDate': '2008-12-03', 'resultsFirstSubmitDate': '2013-12-21', 'studyFirstSubmitQcDate': '2008-12-04', 'lastUpdatePostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-21', 'studyFirstPostDateStruct': {'date': '2008-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated Blood Loss', 'timeFrame': 'Perioperative'}], 'secondaryOutcomes': [{'measure': 'Operating Room Time in Minutes', 'timeFrame': 'Intraoperative time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tissue sealing device', 'Articulating stapling device', 'Radical cystectomy'], 'conditions': ['Bladder Cancer', 'Hemostasis']}, 'descriptionModule': {'briefSummary': 'Evaluate the utility/safety of an FDA-approved tissue sealing device during radical cystectomy as compared to an FDA-approved stapling device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Muscle invasive bladder cancer\n* Male/Female gender\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT00802633', 'briefTitle': 'Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?', 'orgStudyIdInfo': {'id': '081018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Stapling device', 'description': 'Efficacy of stapling device during radical cystectomy', 'interventionNames': ['Device: Stapling device during radical cystectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ligasure Device', 'description': 'Efficacy of ligasure tissue sealing device during radical cystectomy', 'interventionNames': ['Device: Ligasure tissue sealing device']}], 'interventions': [{'name': 'Stapling device during radical cystectomy', 'type': 'DEVICE', 'otherNames': ['Ethicon articulating stapler'], 'description': 'Hemostasis', 'armGroupLabels': ['Stapling device']}, {'name': 'Ligasure tissue sealing device', 'type': 'DEVICE', 'otherNames': ['Tissue sealing device'], 'description': 'Efficacy of tissue sealing device during hemostasis', 'armGroupLabels': ['Ligasure Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Sam S Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'SChang', 'investigatorAffiliation': 'Vanderbilt University'}}}}