Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2026-04-16 @ 7:32 AM
Study NCT ID:
NCT02123992
Status:
TERMINATED
Last Update Posted:
2016-09-07
First Post:
2014-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Elevate Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'whyStopped': 'Astora business is closing', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-06', 'studyFirstSubmitDate': '2014-04-24', 'studyFirstSubmitQcDate': '2014-04-25', 'lastUpdatePostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subjects experiencing adverse events related to device or procedure', 'timeFrame': '36 months'}, {'measure': 'Subjects experiencing vaginal bulge', 'timeFrame': '36 months'}, {'measure': 'Subjects experiencing prolapse at or beyond the hymenal ring [Time Frame: 36 months', 'timeFrame': '36 months'}], 'primaryOutcomes': [{'measure': 'Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures', 'timeFrame': '36 months'}, {'measure': 'Rate of device or procedure related serious adverse events', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures', 'timeFrame': '36 months'}, {'measure': 'Rate of repeat surgery/revision for prolapse arising from the same site/target compartment', 'timeFrame': '36 months'}, {'measure': 'Changes in Quality of Life measured through the following questionaires: PFDI- 20,PFIQ-7, PISQ-12', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pelvic Organ Prolapse']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to further evaluate the safety and efficacy of the Elevate® Apical and Posterior Prolapse Repair System for repair of apical/posterior pelvic organ prolapse in a controlled, post-market cohort study.', 'detailedDescription': "The Harmony 522 study has been terminated due to the closing of the Astora Women's Health business. No other entity will be taking responsibility for this study. The study was terminated with partial subject enrollment complete and therefore no primary or secondary data analysis can be performed. The data from this study resides in a national data base which Astora no longer has access and therefore is another reason why no data analysis can be performed. The national database is owned and managed by the American Urogynecology Society (AUGS). AUGS has access to Astora's data and will at some time in the near future publish results to physicians who are active participants in the registry. Full public disclosure of this data may not occur for a number of years and will be aggregated with data from other study sponsors."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubject is female\n\nSubject is at least 18 years of age\n\nSubject must have documented diagnosis of posterior or posterior and apical vaginal prolapse with leading edge of pelvic organ prolapse at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Bp ≥ 0; or Bp ≥ 0 and C ≥ -1/2 TVL (for a multi-compartment posterior prolapse that includes the apical compartment)\n\nSubject reports a bothersome bulge they can see or feel per PFDI-20, question 3, response of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a bit")\n\nSubject or subject\'s legally authorized representative is willing to provide written informed consent\n\nSubject is willing and able to comply with the follow-up regimen\n\nExclusion Criteria:\n\nSubject is pregnant or intends to become pregnant during the study\n\nSubject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis\n\nSubject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)\n\nSubject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area\n\nSubject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)\n\nSubject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan\'s syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatica)\n\nSubject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis\n\nSubject has uncontrolled diabetes mellitus (DM)\n\nSubject has a known neurologic or medical condition affecting bladder function (e.g., multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit)\n\nSubject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)\n\nSubject is not able to conform to the modified dorsal lithotomy position\n\nSubject is currently participating in or plans to participate in another device or drug study during this study\n\nSubject has a known sensitivity to polypropylene\n\nSubject has had previous prolapse repair with mesh in the target compartment\n\nSubject is planning to undergo a concomitant repair with use of mesh in the non-target compartment'}, 'identificationModule': {'nctId': 'NCT02123992', 'acronym': 'Harmony 522', 'briefTitle': 'Study of the Elevate Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse', 'organization': {'class': 'INDUSTRY', 'fullName': "ASTORA Women's Health"}, 'officialTitle': 'A Prospective, Safety and Efficacy Cohort Study of Elevate® Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse Repair', 'orgStudyIdInfo': {'id': 'PR1206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Elevate Apical and Posterior', 'description': 'The experimental arm of the study will include the implantation of the Elevate Posterior surgical mesh for the treatment of posterior vaginal prolapse', 'interventionNames': ['Device: Elevate Apical and Posterior']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Native Tissue Repair', 'description': 'The control arm of the study will include the treatment of posterior vaginal prolapse using standard surgical sutures', 'interventionNames': ['Procedure: Native Tissue Repair for pelvic organ prolapse']}], 'interventions': [{'name': 'Elevate Apical and Posterior', 'type': 'DEVICE', 'armGroupLabels': ['Elevate Apical and Posterior']}, {'name': 'Native Tissue Repair for pelvic organ prolapse', 'type': 'PROCEDURE', 'armGroupLabels': ['Native Tissue Repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85941', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Urological Associates of Southern Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'The Clark Center for Urogynecology', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'National Center for Advanced Pelvic Surgery', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '46825', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': "Women's Health Advantage", 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '55125', 'city': 'Woodbury', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Metro Urology', 'geoPoint': {'lat': 44.92386, 'lon': -92.95938}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Adult & Pediatric Urology and Urogynecology', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89169', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': "Women's Cancer Center of Nevada", 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08054', 'city': 'Mount Laurel', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Delaware Valley Urology', 'geoPoint': {'lat': 39.934, 'lon': -74.891}}, {'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Princeton Medical Center', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}, {'zip': '07981', 'city': 'Whippany', 'state': 'New Jersey', 'country': 'United States', 'facility': "The Center for Specialized Women's Health", 'geoPoint': {'lat': 40.82454, 'lon': -74.4171}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': "North Shore Women's Health Clinic", 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '12601', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Premier Medical Group', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "The Institute for Female Pelvic Medicine - St. Luke's Hospital", 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '19446', 'city': 'Lansdale', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Center for Women's Health of Lansdale", 'geoPoint': {'lat': 40.2415, 'lon': -75.28379}}, {'zip': '18940', 'city': 'Newtown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Female Pelvic Health Center', 'geoPoint': {'lat': 40.22928, 'lon': -74.93683}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Swan Urogynecology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '76210', 'city': 'Denton', 'state': 'Texas', 'country': 'United States', 'facility': 'The Womens Centre', 'geoPoint': {'lat': 33.21484, 'lon': -97.13307}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas at Galveston', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '78665', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'Lone Star Urogynecology and Continence Center', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '23235', 'city': 'North Chesterfield', 'state': 'Virginia', 'country': 'United States', 'facility': 'Female Pelvic Medicine Institute of Virginia', 'geoPoint': {'lat': 37.38, 'lon': -77.59}}, {'zip': '98027', 'city': 'Issaquah', 'state': 'Washington', 'country': 'United States', 'facility': "Athena Women's Health", 'geoPoint': {'lat': 47.5301, 'lon': -122.03262}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Pelvic Health Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Eric R Sokol, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be shared at a later data by the American Urogynecology Society aggregated with other data extracted from a national registry database.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "ASTORA Women's Health", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}