Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-31 @ 9:08 PM
Study NCT ID:
NCT04829058
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2021-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2032-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2021-03-19', 'studyFirstSubmitQcDate': '2021-03-31', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment CHange', 'timeFrame': 'Post-surgery through study completion, approximately 7 yrs', 'description': 'Objective cure of vaginal or uterine prolapse approximately 7 years after surgery, defined as POP-Q stage ≤2 at point C as determined with physical exam.'}], 'secondaryOutcomes': [{'measure': 'Patient Global Impression of Improvement (PGI-I) or Patient Global Impression of Change (PGI-C) Questionnaire', 'timeFrame': 'Post-surgery through study completion, approximately 7yrs'}, {'measure': 'Pelvic Floor Distress Inventory (PFDI-20) Questionnaire', 'timeFrame': 'Post-surgery through study completion, approximately 7yrs'}, {'measure': 'Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) or Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)', 'timeFrame': 'Post-surgery through study completion, approximately 7yrs'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh', 'POP'], 'conditions': ['Pelvic Organ Prolapse']}, 'descriptionModule': {'briefSummary': 'The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female subjects ≥ 21 years of age:\n\n* with a baseline diagnosis of apical vaginal or uterine prolapse;\n* who had laparotomic or laparoscopic sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse within 7 years of enrolment;\n* where GYNEMESH PS Mesh was used as a bridging material, and;\n* who are willing and able to participate in prospective follow-up.', 'genderDescription': 'Female subjects ≥ 21 years of age', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:\n\n1. Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse\n2. GYNEMESH PS Mesh was used as a bridging material according to the IFU.\n3. Able and willing to participate in follow-up\n4. Subject or authorized representative has signed the approved informed consent\n\nExclusion Criteria\n\nSubjects meeting any of the following criteria will be considered not eligible for enrollment in this study:\n\n1. Subjects \\< 21 years of age at the time of informed consent\n2. Subjects who had transvaginal approach for surgery\n3. Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)'}, 'identificationModule': {'nctId': 'NCT04829058', 'briefTitle': 'GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ethicon, Inc.'}, 'officialTitle': 'A Retrospective and Long-Term Prospective Post Market Clinical Follow-up (PMCF) Study of the GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh', 'orgStudyIdInfo': {'id': 'ESC_2020_02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intervention', 'type': 'DEVICE', 'description': 'There is no intervention, beyond necessary clinical care, in this study. The surgical procedures that were performed in subjects within this study are identical to the surgical procedures the subjects would have received as part of SOC.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19454', 'city': 'North Wales', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Institute for Female Pelvic Medicine', 'geoPoint': {'lat': 40.21094, 'lon': -75.27823}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UMPC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitatsklinikum Tubingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Christine Romanowski', 'role': 'CONTACT', 'email': 'cromanow@its.jnj.com', 'phone': '908-808-6219'}], 'overallOfficials': [{'name': 'Martin Weisberg, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ethicon, Inc.'}]}, 'ipdSharingStatementModule': {'url': 'http://yoda.yale.edu', 'ipdSharing': 'YES', 'description': 'Johnson \\& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ethicon, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}