Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-29 @ 3:36 AM
Study NCT ID:
NCT00774059
Status:
WITHDRAWN
Last Update Posted:
2017-10-12
First Post:
2008-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Safety and Performance of the Orbix Breast Lift System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No EC approval obtained', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'lastUpdateSubmitDate': '2017-10-11', 'studyFirstSubmitDate': '2008-10-15', 'studyFirstSubmitQcDate': '2008-10-15', 'lastUpdatePostDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Result after using the breast lift system,recurrence of ptosis.', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'complications', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast ptosis, Breast lift'], 'conditions': ['Breast Ptosis']}, 'descriptionModule': {'briefSummary': 'The study is using a new breast lift system to complement a breast-lift operation.\n\nIn general there will be recurrence of breast-ptosis after a correcting operation.\n\nWith this device we want to minimize this recurrence and provide an "internal bra".'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.Female subject between 30-50 years of age 2. Subject is referred for mastopexy(breast lifting)due to one of the following reasons:\n\n* Breast ptosis grade I or II (minimal invasive)\n* Breast ptosis grade I to IV (open procedure)\n* pseudoptosis following breast reduction surgery 3. subject willing to participate as evidenced by signing the written informed consent 4. Minimal invasive: breast cup size \\<C\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. history of surgical procedures involving the ribs and rib cage\n3. Osteoporosis\n4. breast implants\n5. breast carcinoma\n6. auto-immune disease -'}, 'identificationModule': {'nctId': 'NCT00774059', 'briefTitle': 'Evaluation of Safety and Performance of the Orbix Breast Lift System', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Phase 1 Study to Evaluate the Safety and Performance of the Orbix Breast Lift System', 'orgStudyIdInfo': {'id': 'MEC 08-1-024'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Breast lift system', 'type': 'DEVICE', 'description': 'During a breast operation for ptosis a device is brought into the breast and attached to the ribs, to provide lifting of the breast'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020AZ', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht Univeristy Hospital', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Marjoes MP Schuckman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Hospital'}, {'name': 'Adi Cohen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Orbix medical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Adi Cohen', 'oldOrganization': 'Orbix Medical'}}}}