Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2026-04-16 @ 6:54 PM
Study NCT ID:
NCT03195361
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2016-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter, Prospective, Non-randomized, Single-arm, Interventional Study for the Evaluation of the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2016-05-01', 'studyFirstSubmitQcDate': '2017-06-19', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in POP-Q points Aa and Ba', 'timeFrame': '36 months', 'description': 'Points Aa and\\\\or Ba are less than -1'}, {'measure': 'Improvement in POP-Q point C:', 'timeFrame': '36 months', 'description': 'Point C at -5 or less'}, {'measure': 'No unexpected serious adverse device related events', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'Achieving normal urinary function:', 'timeFrame': '36 Months', 'description': 'Patient does not experience voiding dysfunction and have negative Urinary Cough Test.'}, {'measure': 'Improvement in Quality Of Life (QoL)', 'timeFrame': '36 Months', 'description': 'Subjective bother involving pelvic floor disorders using validated scales including PFDI-20 and PSIQ-12.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent']}, 'descriptionModule': {'briefSummary': 'A prospective, single arm, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients', 'detailedDescription': 'The SRS implant is intended for transvaginal surgical treatment of anterior vaginal wall prolapse with or without vaginal apex/uterine prolapses'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient has signed the informed consent form and is willing to participate in the clinical study and data collection.\n2. Patient age is between 50 and 75 years old\n3. POP-Q: Aa and/or Ba is at least -1\n\nExclusion Criteria:\n\n1. Patient is pregnant or breastfeeding\n2. Patient is suffering from active infection (on antibiotic therapy)\n3. Patient is planning vaginal delivery\n4. Patient had previous vaginal mesh surgery\n5. Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic, coagulatory or respiratory diseases).\n6. Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.\n7. Malignancy.\n8. Known hypersensitivity to PEEK and/or polypropylene materials.\n9. Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.\n10. Diagnosed with mental or emotional disturbance."}, 'identificationModule': {'nctId': 'NCT03195361', 'briefTitle': 'Multicenter, Prospective, Non-randomized, Single-arm, Interventional Study for the Evaluation of the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lyra Medical Ltd.'}, 'orgStudyIdInfo': {'id': 'CD-14-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-arm', 'description': 'Subjects suffering from anterior POP-Q grade 2 (point Aa and Ba≥ -1) and above, who are scheduled for POP surgery, will be transplanted with the SRS device', 'interventionNames': ['Device: SRS - Self Retaining Support system']}], 'interventions': [{'name': 'SRS - Self Retaining Support system', 'type': 'DEVICE', 'otherNames': ['transvaginal surgical treatment'], 'armGroupLabels': ['Single-arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51544', 'city': 'Bnei Brak', 'country': 'Israel', 'facility': 'Mayanei HaYeshua Medical Center', 'geoPoint': {'lat': 32.08074, 'lon': 34.8338}}, {'city': 'Safed', 'country': 'Israel', 'facility': 'Ziv Medical center', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}, {'zip': '70300', 'city': 'Zrifin', 'country': 'Israel', 'facility': 'Asaf HaRofeh Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lyra Medical Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}