Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-06-11 @ 2:37 PM
Study NCT ID:
NCT05527132
Status:
UNKNOWN
Last Update Posted:
2023-11-08
First Post:
2022-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding the Phenomena of Aging and Rupture of Breast Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-07', 'studyFirstSubmitDate': '2022-08-30', 'studyFirstSubmitQcDate': '2022-09-01', 'lastUpdatePostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The mechanical properties of breast implants will be evaluated by uniaxial tensile tests', 'timeFrame': 'After extraction of breast implants'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Prosthesis Implantation', 'Aging of breast implants', 'Rupture of breast implants'], 'conditions': ['Aging of Breast Implants']}, 'descriptionModule': {'briefSummary': 'Breast implants, like all implantable medical devices, are subject to wear and tear as they age in the body. In addition to this wear and tear, they are subject to external trauma, whether accidental during daily life, during insertion or during mammography.\n\nThe kinetics and mechanisms of aging are poorly studied and the phenomenon of implant rupture is not elucidated. However, studies of older generation implants have shown that implant rupture is correlated with the duration of implantation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female adult (≥18 years old) operated on at the HUS for a change of breast prosthesis, aesthetic or reconstruction, between 2022 and 2024', 'eligibilityCriteria': 'Inclusion criteria:\n\n* Female adult (≥18 years old)\n* operated on at the HUS for a change of breast prosthesis, aesthetic or reconstruction, between 2022 and 2024\n* having not expressed, after information, her opposition to participate in this research.\n\nExclusion criteria:\n\n* Women who have expressed their opposition to participating in the study\n* ruptured prosthesis, associated with a LAGC-AIM, excessive perspiration\n* interfering treatments and associated diseases, history'}, 'identificationModule': {'nctId': 'NCT05527132', 'acronym': 'CRIMA', 'briefTitle': 'Understanding the Phenomena of Aging and Rupture of Breast Implants', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Understanding the Phenomena of Aging and Rupture of Breast Implants', 'orgStudyIdInfo': {'id': '8528'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'laetitia RUFFENACH, MD', 'role': 'CONTACT', 'email': 'laetitia.ruffenach@chru-strasbourg.fr', 'phone': '33 3 68 76 51 67'}, {'name': 'laetitia RUFFENACH, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Frédéric BODIN, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service de Chirurgie Plastique Esthétique et Reconstructrice - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'laetitia RUFFENACH, MD', 'role': 'CONTACT', 'email': 'laetitia.ruffenach@chru-strasbourg.fr', 'phone': '33 3 68 76 51 67'}], 'overallOfficials': [{'name': 'laetitia RUFFENACH, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Chirurgie Plastique Esthétique et Reconstructrice - CHU de Strasbourg - France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}