Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-04 @ 8:10 PM
Study NCT ID:
NCT01673360
Status:
TERMINATED
Last Update Posted:
2016-06-17
First Post:
2012-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D011391', 'term': 'Prolapse'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 401}}, 'statusModule': {'whyStopped': 'Sponsor is winding down business operations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-16', 'studyFirstSubmitDate': '2012-08-23', 'studyFirstSubmitQcDate': '2012-08-27', 'lastUpdatePostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prolapse Efficacy - POP-Q', 'timeFrame': 'annually, upto 5 years', 'description': 'Prolapse Endpoints:\n\n• POP-Q measurement'}, {'measure': 'Urinary Incontinence Endpoints', 'timeFrame': 'annually upto 5 years', 'description': 'Urinary Incontinence Endpoints:\n\n* Cough stress test\n* 1 hour pad weight test\n* Urodynamics'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vaginal repair', 'urinary slings', 'POP', 'SUI', 'prolapse', 'incontinence'], 'conditions': ['Female Stress Incontinence', 'Pelvic Organ Prolapse']}, 'descriptionModule': {'briefSummary': 'To monitor post-market performance through evaluation of short and long-term performance via:\n\n* Efficacy\n* Safety\n* Patient reported outcomes', 'detailedDescription': 'As this is a post-market registry on market approved devices, there will be no formal hypothesis testing. However, points of evaluation will include:\n\n* Characterize the efficacy of the AMS market approved female pelvic health products using standard of care outcome measures and validated quality of life questionnaires\n* Characterize the type, severity, and rate of adverse events related to each AMS market approved female pelvic health product\n* Collect concomitant procedural data related to the pelvic floor area'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients planned to receive at least one (1) target AMS market approved female pelvic health product will be considered for inclusion in the registry.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must meet all of the following criteria to be considered for inclusion in the registry.\n\n * Have a signed Informed Consent Form\n * Have a signed HIPAA Authorization Form or equivalent Patient Privacy Form if required outside of the US\n * Is a female at least 18 years of age\n * Is scheduled to receive at least one (1) AMS market approved female pelvic health implantable product.\n * Is able and willing to participate in the registry\n\nExclusion Criteria:\n\n* Patients will be excluded from the registry if any one of the following criteria is met.\n\n * Patients are contraindicated to receive the target AMS market approved female pelvic health product per the product's IFU"}, 'identificationModule': {'nctId': 'NCT01673360', 'acronym': 'CAPTURE', 'briefTitle': 'Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices', 'organization': {'class': 'INDUSTRY', 'fullName': "ASTORA Women's Health"}, 'officialTitle': 'Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices', 'orgStudyIdInfo': {'id': 'PR1102'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elevate PC', 'description': 'Subjects implanted with Elevate PC', 'interventionNames': ['Device: Elevate PC']}, {'label': 'Mini Arc Pro', 'description': 'Subjects implanted with Mini Arc Pro', 'interventionNames': ['Device: Mini Arc Pro']}, {'label': 'RetroArc', 'description': 'Subjects implanted with RetroArc', 'interventionNames': ['Device: RetroArc']}], 'interventions': [{'name': 'Elevate PC', 'type': 'DEVICE', 'description': 'List of AMS prolapse products', 'armGroupLabels': ['Elevate PC']}, {'name': 'Mini Arc Pro', 'type': 'DEVICE', 'description': 'List of AMS Urinary Incontinence devices', 'armGroupLabels': ['Mini Arc Pro']}, {'name': 'RetroArc', 'type': 'DEVICE', 'description': 'List of AMS Urinary Incontinence devices', 'armGroupLabels': ['RetroArc']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30005', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Medical Research Institute', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '07962', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Morristown Memorial Hospital', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Womancare', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45242', 'city': 'Cinncinatti', 'state': 'Ohio', 'country': 'United States', 'facility': "Seven Hills Women's Health Centers"}, {'zip': '18940', 'city': 'Newtown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Female Pelvic Health Center', 'geoPoint': {'lat': 40.22928, 'lon': -74.93683}}, {'zip': '23235', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Female Pelvic Medicine Institute of Virginia', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': 'K1H 7W9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': "The Ottawa Hospital - Shirley E. Greenberg Women's Health Centre", 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'N8W 5L7', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Windsor Research Office', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': '34070', 'city': 'Montpellier', 'country': 'France', 'facility': 'CMC Beau Soleil', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital BICÊTRE', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '11 10115', 'city': 'Berlin', 'country': 'Germany', 'facility': 'German Pelvic Floor Center, St. Hedwig Hospital', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '16 88069', 'city': 'Tettnang', 'country': 'Germany', 'facility': 'Waldburg-Zeil Kliniken Klinik Tettnang', 'geoPoint': {'lat': 47.66857, 'lon': 9.59132}}, {'city': 'Maribor', 'country': 'Slovenia', 'facility': 'University Medical Centre Maribor', 'geoPoint': {'lat': 46.55583, 'lon': 15.64593}}, {'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Pretoria Urology Hospital', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínico y Provincial de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Beata María Ana de Jesus', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Rio Hortega', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'city': 'Bolton', 'country': 'United Kingdom', 'facility': 'Royal Bolton Hospital', 'geoPoint': {'lat': 53.58333, 'lon': -2.43333}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Glasgow - Southern General Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "ASTORA Women's Health", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}