Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-10 @ 2:05 PM
Study NCT ID:
NCT00541151
Status:
UNKNOWN
Last Update Posted:
2010-08-27
First Post:
2007-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MiniArc Study: Long-Term Effectiveness Trial for AMS Sling Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-08-26', 'releaseDate': '2016-08-22'}, {'resetDate': '2016-10-25', 'releaseDate': '2016-08-29'}], 'estimatedResultsFirstSubmitDate': '2016-08-22'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-26', 'studyFirstSubmitDate': '2007-10-05', 'studyFirstSubmitQcDate': '2007-10-05', 'lastUpdatePostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of long-term effectiveness after implantation of MiniArc sling via qualitative(i.e.UDI-6 and IIQ-7) and quantitative measurement (i.e.pad weight test and cough stress test) in females for treatment of SUI in general post-market use.', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Evaluation of procedural variables of the implantation,outcomes,and long-term safety.These outcomes will be measured via questionnaires, procedural data, and report of adverse events.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stress urinary incontinence in Women'], 'conditions': ['Stress Urinary Incontinence in Women']}, 'descriptionModule': {'briefSummary': 'Multi-center, prospective, single arm study. Qualify patients will receive treatment for stress urinary incontinence by implantation of an AMS Sling System. The study is a long-term evaluation of effectiveness and safety associated with AMS sling systems.', 'detailedDescription': 'This study is a post market study to evaluate variables of the implantation, safety, and outcomes in a representative population (SUI) indicated for AMS sling systems at various time points. The study duration is 2 year with an estimated 200 enrollment. The outcomes of the treatment will be evaluated via pad weight test, cough stress test, QoLs,and other patient administered questionnaires.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Females 18 years or older who have confirmed SUI', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Females 18 years or older who have confirmed SUI defined as involuntary loss of urine that occurs during physical activity, such as coughing, sneezing, laughing, or exercise.\n\nExclusion Criteria:\n\n* Unwilling or unable to sign ICF\n* Unable to understand the study or has a history of non-compliance with medical devices\n* Contradicted for the implantation surgery due to the following: renal sufficiency, urethral diverticulum, fistula, significant prolapse conditions, pregnant, pelvic cancer, compromise immune system,vulvar pain,blood coagulation disorder, and chronic abscesses\n* Pelvic prolapse greater than grade 3\n* Is, in the investigator's opinion, otherwise unsuitable for the study"}, 'identificationModule': {'nctId': 'NCT00541151', 'acronym': 'MiniArc', 'briefTitle': 'MiniArc Study: Long-Term Effectiveness Trial for AMS Sling Systems', 'organization': {'class': 'INDUSTRY', 'fullName': 'American Medical Systems'}, 'officialTitle': 'Long-Term Effectiveness Trial for AMS Sling Systems', 'orgStudyIdInfo': {'id': 'WC0605'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MiniArc', 'type': 'DEVICE', 'otherNames': ['MiniArc or single incision sling'], 'description': 'sling system'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'McKay Urology Research', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Michael Kennelly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McKay Urology Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American Medical Systems', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Audrey Singh- Clinical Project Lead', 'oldOrganization': 'American Medical Systems, Inc.'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-08-22', 'type': 'RELEASE'}, {'date': '2016-08-26', 'type': 'RESET'}, {'date': '2016-08-29', 'type': 'RELEASE'}, {'date': '2016-10-25', 'type': 'RESET'}], 'unpostedResponsibleParty': "ASTORA Women's Health"}}}}