Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-29 @ 4:08 AM
Study NCT ID:
NCT05062733
Status:
RECRUITING
Last Update Posted:
2024-10-31
First Post:
2021-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SEBBIN Round, Anatomical and Biconvex Gluteal Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011475', 'term': 'Prosthesis Failure'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2035-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-30', 'studyFirstSubmitDate': '2021-09-21', 'studyFirstSubmitQcDate': '2021-09-21', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complication rate', 'timeFrame': 'At 10 years of follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complication', 'Prosthesis Durability']}, 'descriptionModule': {'briefSummary': 'This study is part of the clinical evaluation of SEBBIN silicone gel-filled gluteal implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The intended target population for the gluteal Implants is women or men, who desire an increase in volume of the gluteal region for aesthetic or reconstruction reason.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient is a man or a woman ≥ 18 years old at the time of inclusion.\n* The patient is planned for a unilateral or bilateral gluteal implant placement with SEBBIN implants as per investigator decision\n* The patient has been informed of the study, has read the patient informed consent and provided consent for the study in writing.\n\nExclusion Criteria:\n\n* Patient implanted with silicone implants somewhere else in the body.\n* Patient candidate for implantation with custom-designed implants.\n* Participation in another interventional clinical study (participation into an observational study is permitted) with a medicinal product or a medical device in the 30 days prior to enrolment.'}, 'identificationModule': {'nctId': 'NCT05062733', 'briefTitle': 'SEBBIN Round, Anatomical and Biconvex Gluteal Implants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Groupe SEBBIN'}, 'officialTitle': 'Prospective Observational Study About SEBBIN Gluteal Implants', 'orgStudyIdInfo': {'id': 'PEC 20-07-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '00193', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Valerio Badiali, MD', 'role': 'CONTACT', 'email': 'info@valeriobadiali.com', 'phone': '+39 393 968 3014'}, {'name': 'Valerio Badiali, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Estetico Italiano', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '2582', 'city': 'The Hague', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Philippe Levan, MD', 'role': 'CONTACT', 'email': 'info@essentialaesthetics.net', 'phone': '925.855.1773'}, {'name': 'Philippe Levan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical Clinic "Essential Aesthetics"', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe SEBBIN', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}