Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 9:27 PM
Study NCT ID:
NCT06147661
Status:
UNKNOWN
Last Update Posted:
2023-11-27
First Post:
2023-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Aesthetic Breast Augmentation: Comparative Study Between Breast Implants and Autograft of Adipose Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 119}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-01-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2023-11-22', 'lastUpdatePostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient woman satisfaction', 'timeFrame': '1 to 4 years after breast implants', 'description': 'This satisfaction will be assessed using a remote satisfaction interview'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Prosthesis', 'Breast Implants'], 'conditions': ['Breast Implants']}, 'descriptionModule': {'briefSummary': 'The use of autograft of adipose tissue for aesthetic breast augmentation is increasing year after year. According to the latest meta-analysis of 2016, autograft of adipose tissue in augmentation mastoplasty seems to be a promising method with a satisfactory resorption volume and patient and surgeon satisfaction. However, this technique allows for small to moderate breast augmentation and is therefore not suitable for patients wanting a significant increase.\n\nBreast prostheses allow a significant increase. Numerous studies have shown an improvement in patient satisfaction and quality of life assessed using the BREAST-Q questionnaire.\n\nOn the other hand, very few studies have objectively evaluated the satisfaction of patients who have benefited from an autograft of adipose tissue as part of aesthetic breast augmentation. No study has yet compared the satisfaction of patients who have benefited from breast implants or lipofilling.\n\nThe aim of this study is to compare the satisfaction of patients who have benefited from breast augmentation by prosthesis or by lipofilling using a remote satisfaction interview.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult woman (age ≥ 18 years) having benefited from primary aesthetic breast augmentation at Strasbourg University Hospital between June 27, 2017 and June 27, 2022', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult woman (age ≥ 18 years)\n* having benefited from primary aesthetic breast augmentation at Strasbourg University Hospital between June 27, 2017 and June 27, 2022\n* not opposing the reuse of its data for scientific research purposes.\n\nExclusion Criteria:\n\n* Woman who expressed her opposition to the reuse of her data for scientific research purposes\n* Woman with a breast malformation: tuberous breasts or breast asymmetry of more than one cup\n* Woman with comprehension difficulties\n* Woman under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT06147661', 'acronym': 'AMEP', 'briefTitle': 'Primary Aesthetic Breast Augmentation: Comparative Study Between Breast Implants and Autograft of Adipose Tissue', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Primary Aesthetic Breast Augmentation: Comparative Study Between Breast Implants and Autograft of Adipose Tissue', 'orgStudyIdInfo': {'id': '8954'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric BODIN, MD, PhD', 'role': 'CONTACT', 'email': 'frederic.bodin@chru-strasbourg.fr', 'phone': '33 3 68 76 51 67'}, {'name': 'Anna AUQUE, MD', 'role': 'CONTACT', 'email': 'Anna.auque@yahoo.fr', 'phone': '33 3 68 76 51 67'}, {'name': 'Frédéric BODIN', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anna AUQUE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de Chirurgie Plastique, Reconstructrice et Esthétique - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Frédéric BODIN, MD, PhD', 'role': 'CONTACT', 'email': 'frederic.bodin@chru-strasbourg.fr', 'phone': '33 3 68 76 51 67'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}