Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-27 @ 9:52 PM
Study NCT ID:
NCT01223066
Status:
WITHDRAWN
Last Update Posted:
2022-08-25
First Post:
2010-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Macrolane Prospective Survey
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{'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no patients recruited', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2010-10-15', 'studyFirstSubmitQcDate': '2010-10-15', 'lastUpdatePostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Macrolane'], 'conditions': ['Females Recently Treated With Macrolane VRF in the Breasts']}, 'descriptionModule': {'briefSummary': 'The study objective is to evaluate the long term safety when Macrolane Volume Restoration Factor is used in female breasts in clinical practice.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participating clinics will ask women who have been treated with Macrolane in the breasts in clinical practice, to participate in this survey.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females recently treated with Macrolane Volume Restoration Factor in the breasts.\n* Signed informed consent\n\nExclusion Criteria:\n\n* There are no exclusion criteria'}, 'identificationModule': {'nctId': 'NCT01223066', 'briefTitle': 'Macrolane Prospective Survey', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Multi-center, Non-interventional, Prospective Study to Monitor Long Term Safety in Female Subjects After Treatment With Macrolane Volume Restoration Factor 20 and/or Macrolane Volume Restoration Factor 30 in the Breasts.', 'orgStudyIdInfo': {'id': '31GB0906'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women treated with Macrolane in the breasts'}]}, 'contactsLocationsModule': {'locations': [{'zip': '115 42', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Akademikliniken', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Per Hedén, Md PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Akademikliniken Stockholm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pharma Consulting Group AB', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}