Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT01320618
Status:
COMPLETED
Last Update Posted:
2016-08-11
First Post:
2011-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Cohort Study of Robotic Assisted Laparoscopic Sacrocolpopexy Using MPATHY Restorelle Mesh
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014596', 'term': 'Uterine Prolapse'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-10', 'studyFirstSubmitDate': '2011-03-21', 'studyFirstSubmitQcDate': '2011-03-21', 'lastUpdatePostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['uterine prolapse', 'vaginal prolapse', 'mesh erosion', 'urinary incontinence', 'bowel symptoms'], 'conditions': ['Pelvic Organ Prolapse', 'Urinary Incontinence', 'Mesh Erosion']}, 'descriptionModule': {'briefSummary': 'Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to long term outcome. This advanced procedure is offered at Morristown Memorial. This protocol will review the one year outcome of patients who underwent this procedure using a polypropylene mesh. These outcomes will include anatomical and quality of life measures.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Our study population will be woman who underwent Robotic assisted laparoscopic sacral colpopexy at the Morristown Memorial Hospital for correction of pelvic organ prolapseusing synthetic polypropelene mesh.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient receiving Robotic assisted laparoscopic sacral colpopexy with polypropylene mesh\n\nExclusion Criteria:\n\n* Other graft material than polypropylene mesh\n* Enrollment in another study'}, 'identificationModule': {'nctId': 'NCT01320618', 'acronym': 'MPATHY', 'briefTitle': 'Prospective Cohort Study of Robotic Assisted Laparoscopic Sacrocolpopexy Using MPATHY Restorelle Mesh', 'organization': {'class': 'OTHER', 'fullName': 'Atlantic Health System'}, 'orgStudyIdInfo': {'id': 'R09-06-003'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlantic Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'charbel salamon', 'investigatorAffiliation': 'Atlantic Health System'}}}}