Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-01-04 @ 10:57 AM
Study NCT ID:
NCT02438332
Status:
COMPLETED
Last Update Posted:
2016-07-25
First Post:
2015-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 330}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-22', 'studyFirstSubmitDate': '2015-05-06', 'studyFirstSubmitQcDate': '2015-05-07', 'lastUpdatePostDateStruct': {'date': '2016-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Reoperations of All Cause Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm® 1 or TruForm® 2 Breast Implants', 'timeFrame': '4 Years'}], 'secondaryOutcomes': [{'measure': 'Incidence (by Product Type) of First Reoperation Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm®1 or TruForm® 2 Breast Implants', 'timeFrame': '4 Years'}, {'measure': 'Reasons For Primary Augmentation', 'timeFrame': '4 Years'}, {'measure': 'Time From the Date of Implant Until First Reoperation', 'timeFrame': '4 Years'}, {'measure': 'Reasons For Reoperation Incidence', 'timeFrame': '4 Years'}, {'measure': 'Incidences of Implant Removal With Replacement', 'timeFrame': '4 Years'}, {'measure': 'Incidences of Implant Removal Without Replacement', 'timeFrame': '4 Years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Implantation']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the incidence of reoperations associated with the use of smooth and textured NATRELLE® INSPIRA® TruForm® 1 and TruForm® 2 devices in patients who have undergone primary breast augmentation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects that have undergone a primary breast augmentation for aesthetic reasons with NATRELLE® INSPIRA® TruForm® 1 or TruForm® 2 implant.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary breast augmentation (either bilateral or unilateral) operated on by the investigating surgeon with an infra-mammary approach smooth or textured NATRELLE® INSPIRA® TruForm® 1 or 2 device\n* Primary breast augmentation 2 to 4 years (24-48 months) prior to data collection\n* Subfascial, submuscular, dual plane or subglandular implant placement\n\nExclusion Criteria:\n\n* Breast augmentation for Poland Syndrome or amastia\n* Breast reconstruction following mastectomy\n* Revision or secondary breast reconstruction\n* Non NATRELLE® INSPIRA® device implanted at initial breast augmentation\n* Women diagnosed with breast disease considered to be pre-malignant or malignant prior to or at the time of primary breast augmentation\n* Surgical procedures of the breast not related to the primary breast augmentation (e.g. excision of significant skin lesions or a biopsy) occurring prior to or at the time of primary augmentation that may adversely affect the aesthetic outcome in the opinion of the investigator\n* Axillary or peri-areolar approach\n* Mastopexy augmentation'}, 'identificationModule': {'nctId': 'NCT02438332', 'acronym': 'RANBI-I', 'briefTitle': 'Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'GMA-CAN-PLS-0337'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NATRELLE® INSPIRA® TruForm® 1 (Smooth)', 'description': 'Subjects receiving primary breast augmentation with smooth NATRELLE® INSPIRA® TruForm® 1 breast implants', 'interventionNames': ['Device: Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants']}, {'label': 'NATRELLE® INSPIRA® TruForm® 1 (Textured)', 'description': 'Subjects receiving primary breast augmentation with textured NATRELLE® INSPIRA® TruForm® 1 breast implants', 'interventionNames': ['Device: Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants']}, {'label': 'NATRELLE® INSPIRA® TruForm® 2 (Smooth)', 'description': 'Subjects receiving primary breast augmentation with smooth NATRELLE® INSPIRA® TruForm® 2 breast implants', 'interventionNames': ['Device: Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants']}, {'label': 'NATRELLE® INSPIRA® TruForm® 2 (Textured)', 'description': 'Subjects receiving primary breast augmentation with textured NATRELLE® INSPIRA® TruForm® 2 breast implants', 'interventionNames': ['Device: Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants']}], 'interventions': [{'name': 'Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants', 'type': 'DEVICE', 'otherNames': ['Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)'], 'description': 'Surgical implant', 'armGroupLabels': ['NATRELLE® INSPIRA® TruForm® 1 (Smooth)']}, {'name': 'Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants', 'type': 'DEVICE', 'otherNames': ['Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)'], 'description': 'surgical implant', 'armGroupLabels': ['NATRELLE® INSPIRA® TruForm® 1 (Textured)']}, {'name': 'Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants', 'type': 'DEVICE', 'otherNames': ['Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)'], 'description': 'surgical implant', 'armGroupLabels': ['NATRELLE® INSPIRA® TruForm® 2 (Smooth)']}, {'name': 'Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants', 'type': 'DEVICE', 'otherNames': ['Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)'], 'description': 'surgical implant', 'armGroupLabels': ['NATRELLE® INSPIRA® TruForm® 2 (Textured)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T1L 1B7', 'city': 'Banff', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Banff Plastic Surgery', 'geoPoint': {'lat': 51.17622, 'lon': -115.56982}}, {'zip': 'T2H 0L8', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Macleod Trail Plastic Surgery', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T5M 327', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Jonathan Toy', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V2Y 0C8', 'city': 'Langley', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Y.E.S MedSpa & Cosmetic Surgery Centre', 'geoPoint': {'lat': 49.10107, 'lon': -122.65883}}, {'zip': 'L6J 7W5', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Institute of Cosmetic and Laser Surgery', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'K1Z 8R9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Plastic Surgery: Dr. Howard Silverman', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M2J 1V1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Rice Cosmetic Surgery', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M2P 2C2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cosmedical Rejuvenation Clinic', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5R 2J3', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Yorkville Institute of Plastic Surgery', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N2J 1M3', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'SpaSurgica', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'zip': 'J4B 7M6', 'city': 'Boucherville', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de Medecine et de Chirurgie Ambulatoires Isomed', 'geoPoint': {'lat': 45.59104, 'lon': -73.43605}}, {'zip': 'H3G 1B9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CCPEM', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H9R 5N3', 'city': 'Pointe-Claire', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Cosmedica', 'geoPoint': {'lat': 45.44868, 'lon': -73.81669}}, {'zip': 'G1V 1R4', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinique de Chirurgie Plastique et Esthétique de la Haute-Ville', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G1V 4M6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Sebastien Nguyen MD Inc.', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'N2L 3S2', 'city': 'Waterloo', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Cosmetic Surgery Clinic', 'geoPoint': {'lat': 45.35008, 'lon': -72.51582}}, {'zip': 'H3Z 1S3', 'city': 'Westmount', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Sandra McGill MD Inc.', 'geoPoint': {'lat': 45.48341, 'lon': -73.59918}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}