Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-02-25 @ 12:57 AM
Study NCT ID:
NCT02921451
Status:
UNKNOWN
Last Update Posted:
2019-08-14
First Post:
2016-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2016-09-23', 'studyFirstSubmitQcDate': '2016-09-29', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who present with recurrence of uterine prolapse following surgery as assessed by failing to meet success criteria', 'timeFrame': 'Within first two years after surgical procedure', 'description': 'Success criteria will be defined through the examination of patient\'s Prolapse Quantification System Assessment (POPQ) score of C -1 or less and patient\'s report of bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 0 or 1 (i.e. response of "not at all"). Failure to meet this criteria will be considered recurrence of uterine prolapse.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Uterine Prolapse']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the long term performance of Restorelle system for the treatment of uterine prolapse.', 'detailedDescription': 'This study is being done to evaluate the performance of the Restorelle system, which uses Smartmesh - an ultra-lightweight mesh for uterine prolapse management. Most patients undergo a hysterectomy i.e. removal of the uterus when they have a prolapse. However, this has often been found to be an unnecessary operation. The investigators are studying the use of the Restorelle mesh system to preserve the uterus when there is a uterine prolapse.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is female.\n2. Subject is at least 18 years of age.\n3. Subjects who have already made the decision to proceed with uterine prolapse surgery using Restorelle Mesh.\n4. Subject has uterine prolapse defined by Prolapse Quantification System Assessment (POPQ) score of C -2 or greater.\n5. Subject reports a bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 2 or higher (i.e. response of "somewhat", "moderately" or "quite a bit").\n6. Subject is willing to provide written informed consent.\n7. Subject is willing and able to comply with follow-up regimen.\n\nExclusion Criteria:\n\n1. Subject is pregnant or intends to become pregnant in the future.\n2. Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical).\n3. Subject has undergone any previous repair for pelvic organ prolapse.\n4. Subject has undergone a hysterectomy.\n5. Subject lacks competency of the English language.'}, 'identificationModule': {'nctId': 'NCT02921451', 'briefTitle': 'Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse', 'organization': {'class': 'OTHER', 'fullName': "Michigan Institution of Women's Health PC"}, 'officialTitle': 'Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse', 'orgStudyIdInfo': {'id': 'IISP 16-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Restorelle Smartmesh', 'description': 'Surgical procedure for treatment of uterine prolapse will use the device, Restorelle Smartmesh.', 'interventionNames': ['Device: Restorelle Smartmesh']}], 'interventions': [{'name': 'Restorelle Smartmesh', 'type': 'DEVICE', 'description': 'Patients will have surgery using the device, Restorelle Smartmesh, for treatment of uterine prolapse.', 'armGroupLabels': ['Restorelle Smartmesh']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48125', 'city': 'Dearborn', 'state': 'Michigan', 'country': 'United States', 'facility': 'Advanced Urogynecology of Michigan, P.C.', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}], 'overallOfficials': [{'name': 'Salil Khandwala', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Advanced Urogynecology of Michigan, P.C.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Michigan Institution of Women's Health PC", 'class': 'OTHER'}, 'collaborators': [{'name': 'Coloplast A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Salil Khandwala', 'investigatorAffiliation': "Michigan Institution of Women's Health PC"}}}}