Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-02 @ 2:45 AM
Study NCT ID:
NCT04968457
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2021-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 908}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2021-07-06', 'studyFirstSubmitQcDate': '2021-07-19', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complication', 'timeFrame': 'At 10 years of follow-up', 'description': 'complication rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Implant; Complications']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to allow Groupe SEBBIN to communicate to competent authorities and to the scientific community data relative to the safety and effectiveness of SEBBIN silicone gel-filled breast implants.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Enrollment in the study was proposed to women over 18-year who were scheduled for a breast augmentation or breast reconstruction with SEBBIN silicone gel-filled breast implants.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient is at least 18-year-old.\n* The patient is genetically a woman.\n* The patient is candidate to a breast augmentation or breast reconstruction with silicone gel-filled breast implants.\n* The patient gets all information regarding the study and signs the informed consent relative to the use of her personal data.\n\nExclusion Criteria:\n\n* The patient is pregnant or breastfeeding.\n* The patient has silicone implants somewhere else than in the breast.\n* The patient was diagnosed with one of the following pathologies:\n\n * Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.\n * Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.\n * Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.\n* The patient has a pathology that could delay healing (does not apply to the reconstruction group).\n* The patient has cancer (does not apply to the reconstruction group).\n* The patient has anatomical or physiological conditions that could lead to postoperative complications.'}, 'identificationModule': {'nctId': 'NCT04968457', 'acronym': 'IM02', 'briefTitle': 'Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Groupe SEBBIN'}, 'officialTitle': 'Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants', 'orgStudyIdInfo': {'id': 'PEC 15-10-001'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe SEBBIN', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}