Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-31 @ 1:58 AM
Study NCT ID:
NCT00196495
Status:
COMPLETED
Last Update Posted:
2006-12-18
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D014596', 'term': 'Uterine Prolapse'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-12', 'completionDateStruct': {'date': '2005-11'}, 'lastUpdateSubmitDate': '2006-12-15', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2006-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of the TVM treatment in curing vaginal prolapse as indicated by recurrence rate.'}], 'secondaryOutcomes': [{'measure': 'Intraoperative complication'}, {'measure': 'Patient tolerance of the synthetic mesh placed'}, {'measure': 'Postoperative complications'}, {'measure': 'Quality of life'}]}, 'conditionsModule': {'conditions': ['Vaginal Prolapse']}, 'descriptionModule': {'briefSummary': 'Pelvic floor prolapse is a general term used to describe various clinical conditions that are associated with pelvic floor (muscles that support the vagina) relaxation in female patients.Pelvic floor prolapse is thought to result from a stretching, weakening or tearing of the soft tissue structures that support the pelvic organs. These tissues become compromised because of a weakened or damaged.The purpose of the study will be to demonstrate the usability of Polypropylene Mesh for prolapse repair, using the TVM technique.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female candidate for surgical pelvic floor repair (at least ICS stage II symptomatic prolapse).\n* Patient who is at leat 21 years of age.\n* Patient whose family is complete.\n* Patient may not have uncontrolled diabetes.\n\nExclusion Criteria:\n\n* Patients may not have coagulation disorders.'}, 'identificationModule': {'nctId': 'NCT00196495', 'briefTitle': 'Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ethicon, Inc.'}, 'officialTitle': 'Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse', 'orgStudyIdInfo': {'id': '2003-016'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Polypropylene Mesh', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Martin Weisberg, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ethicon, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ethicon, Inc.', 'class': 'INDUSTRY'}}}}