Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-01 @ 2:06 PM
Study NCT ID:
NCT00758667
Status:
TERMINATED
Last Update Posted:
2014-12-10
First Post:
2008-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Chemically Assisted Capsulectomy-A New Clinical Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D057910', 'term': 'Implant Capsular Contracture'}], 'ancestors': [{'id': 'D005549', 'term': 'Foreign-Body Reaction'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011475', 'term': 'Prosthesis Failure'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015080', 'term': 'Mesna'}], 'ancestors': [{'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bruce.shack@vanderbilt.edu', 'phone': '615-936-0160', 'title': 'R. Bruce Shack, MD', 'organization': 'Vanderbilt University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'one year', 'eventGroups': [{'id': 'EG000', 'title': 'Standard', 'description': 'Standard procedure or capsulectomy for removal of capsule;', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mesna', 'description': 'The use of Mesna of removal of capsule for capsular contracture.\n\nMesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard', 'description': 'Standard procedure or capsulectomy for removal of capsule; no mesna\n\nMesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed'}, {'id': 'OG001', 'title': 'Mesna', 'description': 'The use of Mesna of removal of capsule for capsular contracture.\n\nMesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one year', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard', 'description': 'Standard procedure or capsulectomy for removal of capsule;'}, {'id': 'OG001', 'title': 'Mesna', 'description': 'The use of Mesna of removal of capsule for capsular contracture.\n\nMesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one year', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard', 'description': 'Standard procedure or capsulectomy for removal of capsule;'}, {'id': 'FG001', 'title': 'Mesna', 'description': 'The use of Mesna of removal of capsule for capsular contracture.\n\nMesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard', 'description': 'Standard procedure or capsulectomy for removal of capsule; no mesna\n\nMesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed'}, {'id': 'BG001', 'title': 'Mesna', 'description': 'The use of Mesna of removal of capsule for capsular contracture.\n\nMesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Participants with capsular contracture after breast implants that elected to have capsule removed and implant exchanged; followup for recurrence of capsulsar contracture'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'preliminary analysis showed no difference', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-08', 'studyFirstSubmitDate': '2008-09-23', 'resultsFirstSubmitDate': '2013-12-23', 'studyFirstSubmitQcDate': '2008-09-23', 'lastUpdatePostDateStruct': {'date': '2014-12-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-08', 'studyFirstPostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['capsular contracture', 'capsulectomy', 'mesna', 'Capsular contracture after breast implant placement'], 'conditions': ['Implant Capsular Contracture']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.', 'detailedDescription': 'Mesna is a FDA approved drug for the treatment of respiratory diseases and is used a protective agent against drugs in oncology patients. It has also been used in Gynecologic surgery and ENT. Mesna is a drug that breaks down adhesions between tissue layers.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All females undergoing capsulectomy\n\nExclusion Criteria:\n\n* All pregnant women and nursing mothers will be exclued'}, 'identificationModule': {'nctId': 'NCT00758667', 'briefTitle': 'Chemically Assisted Capsulectomy-A New Clinical Approach', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Chemically Assisted Capsulectomy-A New Clinical Approach', 'orgStudyIdInfo': {'id': '010518'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard treatment', 'description': 'Standard treatment'}, {'type': 'EXPERIMENTAL', 'label': 'Use of Mesna', 'description': 'Standard surgical procedure with Mesna', 'interventionNames': ['Drug: Mesna']}], 'interventions': [{'name': 'Mesna', 'type': 'DRUG', 'description': 'B. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed', 'armGroupLabels': ['Use of Mesna']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bruce Shack, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbit Unviersity Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'R. Bruce Shack, MD', 'investigatorFullName': 'R. Bruce Shack', 'investigatorAffiliation': 'Vanderbilt University'}}}}