Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-28 @ 10:51 PM
Study NCT ID:
NCT01134003
Status:
COMPLETED
Last Update Posted:
2010-05-31
First Post:
2010-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Large Multi-Center Database of Women Who Have Had and Are Going to Have Surgical Correction of Their Pelvic Organ Prolapse Using the Gynecare Prolift System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-28', 'studyFirstSubmitDate': '2010-05-27', 'studyFirstSubmitQcDate': '2010-05-28', 'lastUpdatePostDateStruct': {'date': '2010-05-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gynecare Prolift', 'Pelvic organ prolapse', 'forming a large database of women who have recieve Gynecare prolift system'], 'conditions': ['Pelvic Organ Prolapse']}, 'descriptionModule': {'briefSummary': 'retrospective and prospective data collection for a database. Patients will have had or are going to have a repair of their pelvic organ prolapse using the Gynecare mesh Prolift System'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'women receiving surgery for their pelvic organ prolapse using the Gynecare mesh kit called Prolift', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women recieving surgery for their pelvic organ prolapse using the Gynecare mesh kit called Prolift\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01134003', 'briefTitle': 'A Large Multi-Center Database of Women Who Have Had and Are Going to Have Surgical Correction of Their Pelvic Organ Prolapse Using the Gynecare Prolift System', 'organization': {'class': 'OTHER', 'fullName': 'The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania'}, 'officialTitle': 'A Large Multi-Center Database of Women Who Have Had and Are Going to Have Surgical Correction of Their Pelvic Organ Prolapse Using the Gynecare Prolift System', 'orgStudyIdInfo': {'id': 'SLHN 2007-98'}}, 'contactsLocationsModule': {'locations': [{'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Institute for Female Pelvic Medicine and Reconstructive Surgery', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Vincent Lucente', 'oldOrganization': 'Institute for Female Pelvic Medicine'}}}}