Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-28 @ 2:08 PM
Study NCT ID:
NCT01145235
Status:
COMPLETED
Last Update Posted:
2022-08-25
First Post:
2010-06-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Swedish Macrolane Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2010-06-15', 'studyFirstSubmitQcDate': '2010-06-15', 'lastUpdatePostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To document the incidence of breast cancer in female subjects after treatment with Macrolane VRFs in the breasts when the product is used in clinical practice.', 'timeFrame': '2010-2015'}]}, 'conditionsModule': {'keywords': ['Breast augmentation with Macrolane'], 'conditions': ['Breast Augmentation']}, 'descriptionModule': {'briefSummary': 'A Registry to monitor long term safety in female subjects after treatment with Macrolane VRF20 and/or MacrolaneT VRF30 in the breasts.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All clinics treating females with Macrolane in the breast will be asked to participate.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Females previously treated with Macrolane VRF in the breasts\n2. Females continuously being treated with Macrolane VRF in the breasts, initial treatment or re-treatment.\n\nExclusion Criteria:\n\nNo exclusion criteria'}, 'identificationModule': {'nctId': 'NCT01145235', 'briefTitle': 'Swedish Macrolane Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'orgStudyIdInfo': {'id': '31GB0905'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Females previously treated with Macrolane in their breasts.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Dr Per Hedén', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}