Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-03-02 @ 1:52 AM
Study NCT ID:
NCT01853605
Status:
TERMINATED
Last Update Posted:
2015-08-11
First Post:
2013-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'title': 'Allergan Inc.,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Adverse event (AE) data experienced by ≥5% of subjects are recorded as an outcome measure.', 'eventGroups': [{'id': 'EG000', 'title': 'Augmentation', 'description': 'Women undergoing breast augmentation.', 'otherNumAtRisk': 1939, 'otherNumAffected': 0, 'seriousNumAtRisk': 1939, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Revision-Augmentation', 'description': 'Women undergoing revision of previous breast augmentation.', 'otherNumAtRisk': 693, 'otherNumAffected': 0, 'seriousNumAtRisk': 693, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Reconstruction', 'description': 'Women undergoing breast reconstruction.', 'otherNumAtRisk': 751, 'otherNumAffected': 0, 'seriousNumAtRisk': 751, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Revision-Reconstruction', 'description': 'Women undergoing revision of previous breast reconstruction.', 'otherNumAtRisk': 428, 'otherNumAffected': 0, 'seriousNumAtRisk': 428, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subject Satisfaction With Breast Implants on a 5-Point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1929', 'groupId': 'OG000'}, {'value': '688', 'groupId': 'OG001'}, {'value': '740', 'groupId': 'OG002'}, {'value': '419', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Augmentation', 'description': 'Women undergoing breast augmentation.'}, {'id': 'OG001', 'title': 'Revision-Augmentation', 'description': 'Women undergoing revision of previous breast augmentation.'}, {'id': 'OG002', 'title': 'Reconstruction', 'description': 'Women undergoing breast reconstruction.'}, {'id': 'OG003', 'title': 'Revision-Reconstruction', 'description': 'Women undergoing revision of previous breast reconstruction.'}], 'classes': [{'title': 'Definitely Satisfied', 'categories': [{'measurements': [{'value': '1772', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}, {'value': '542', 'groupId': 'OG002'}, {'value': '295', 'groupId': 'OG003'}]}]}, {'title': 'Somewhat Satisfied', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': "Subject satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for subject's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the subject reports different responses for the left and right breasts.", 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants, who completed the 5 year follow-up visit, and had data at the time point.'}, {'type': 'PRIMARY', 'title': 'Investigator Satisfaction With Breast Implants on a 5-Point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1922', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}, {'value': '745', 'groupId': 'OG002'}, {'value': '418', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Augmentation', 'description': 'Women undergoing breast augmentation.'}, {'id': 'OG001', 'title': 'Revision-Augmentation', 'description': 'Women undergoing revision of previous breast augmentation.'}, {'id': 'OG002', 'title': 'Reconstruction', 'description': 'Women undergoing breast reconstruction.'}, {'id': 'OG003', 'title': 'Revision-Reconstruction', 'description': 'Women undergoing revision of previous breast reconstruction.'}], 'classes': [{'title': 'Definitely Satisfied', 'categories': [{'measurements': [{'value': '1798', 'groupId': 'OG000'}, {'value': '560', 'groupId': 'OG001'}, {'value': '564', 'groupId': 'OG002'}, {'value': '310', 'groupId': 'OG003'}]}]}, {'title': 'Somewhat Satisfied', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': "Investigator satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for Investigator's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the Investigator reports different responses for the left and right breasts.", 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants, who completed the 5 year follow-up visit, and had data at the time point.'}, {'type': 'PRIMARY', 'title': 'Local Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1939', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '751', 'groupId': 'OG002'}, {'value': '428', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Augmentation', 'description': 'Women undergoing breast augmentation.'}, {'id': 'OG001', 'title': 'Revision-Augmentation', 'description': 'Women undergoing revision of previous breast augmentation.'}, {'id': 'OG002', 'title': 'Reconstruction', 'description': 'Women undergoing breast reconstruction.'}, {'id': 'OG003', 'title': 'Revision-Reconstruction', 'description': 'Women undergoing revision of previous breast reconstruction.'}], 'classes': [{'title': 'Capsular Contracture', 'categories': [{'measurements': [{'value': '3.27', 'groupId': 'OG000', 'lowerLimit': '2.56', 'upperLimit': '4.16'}, {'value': '6.33', 'groupId': 'OG001', 'lowerLimit': '4.74', 'upperLimit': '8.45'}, {'value': '6.48', 'groupId': 'OG002', 'lowerLimit': '4.92', 'upperLimit': '8.51'}, {'value': '7.29', 'groupId': 'OG003', 'lowerLimit': '5.19', 'upperLimit': '10.21'}]}]}, {'title': 'Asymmetry', 'categories': [{'measurements': [{'value': '0.83', 'groupId': 'OG000', 'lowerLimit': '0.51', 'upperLimit': '1.35'}, {'value': '0.87', 'groupId': 'OG001', 'lowerLimit': '0.39', 'upperLimit': '1.93'}, {'value': '5.94', 'groupId': 'OG002', 'lowerLimit': '4.46', 'upperLimit': '7.90'}, {'value': '3.32', 'groupId': 'OG003', 'lowerLimit': '1.98', 'upperLimit': '5.54'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Local complications are the cumulative complications occurring in at least 5% of subjects in 1 or more cohorts over the duration of the study. The Kaplan-Meier risk rate is presented.', 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants who completed the 5 year follow-up visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Augmentation', 'description': 'Women undergoing breast augmentation.'}, {'id': 'FG001', 'title': 'Revision-Augmentation', 'description': 'Women undergoing revision of previous breast augmentation.'}, {'id': 'FG002', 'title': 'Reconstruction', 'description': 'Women undergoing breast reconstruction.'}, {'id': 'FG003', 'title': 'Revision-Reconstruction', 'description': 'Women undergoing revision of previous breast reconstruction.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1939'}, {'groupId': 'FG001', 'numSubjects': '693'}, {'groupId': 'FG002', 'numSubjects': '751'}, {'groupId': 'FG003', 'numSubjects': '428'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1939'}, {'groupId': 'FG001', 'numSubjects': '693'}, {'groupId': 'FG002', 'numSubjects': '751'}, {'groupId': 'FG003', 'numSubjects': '428'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was discontinued following product approval.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1939', 'groupId': 'BG000'}, {'value': '693', 'groupId': 'BG001'}, {'value': '751', 'groupId': 'BG002'}, {'value': '428', 'groupId': 'BG003'}, {'value': '3811', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Augmentation', 'description': 'Women undergoing breast augmentation.'}, {'id': 'BG001', 'title': 'Revision-Augmentation', 'description': 'Women undergoing revision of previous breast augmentation.'}, {'id': 'BG002', 'title': 'Reconstruction', 'description': 'Women undergoing breast reconstruction.'}, {'id': 'BG003', 'title': 'Revision-Reconstruction', 'description': 'Women undergoing revision of previous breast reconstruction.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.0', 'spread': '8.65', 'groupId': 'BG000'}, {'value': '46.2', 'spread': '9.96', 'groupId': 'BG001'}, {'value': '49.8', 'spread': '10.03', 'groupId': 'BG002'}, {'value': '53.5', 'spread': '9.11', 'groupId': 'BG003'}, {'value': '42.5', 'spread': '11.52', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1939', 'groupId': 'BG000'}, {'value': '693', 'groupId': 'BG001'}, {'value': '751', 'groupId': 'BG002'}, {'value': '428', 'groupId': 'BG003'}, {'value': '3811', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3811}}, 'statusModule': {'whyStopped': 'The study was discontinued following product approval.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-16', 'studyFirstSubmitDate': '2013-05-13', 'resultsFirstSubmitDate': '2015-07-16', 'studyFirstSubmitQcDate': '2013-05-13', 'lastUpdatePostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-16', 'studyFirstPostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject Satisfaction With Breast Implants on a 5-Point Scale', 'timeFrame': '5 years', 'description': "Subject satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for subject's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the subject reports different responses for the left and right breasts."}, {'measure': 'Investigator Satisfaction With Breast Implants on a 5-Point Scale', 'timeFrame': '5 years', 'description': "Investigator satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for Investigator's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the Investigator reports different responses for the left and right breasts."}, {'measure': 'Local Complications', 'timeFrame': '5 years', 'description': 'Local complications are the cumulative complications occurring in at least 5% of subjects in 1 or more cohorts over the duration of the study. The Kaplan-Meier risk rate is presented.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Augmentation', 'Breast Reconstruction', 'Breast Implant Revision']}, 'descriptionModule': {'briefSummary': 'Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast augmentation, reconstruction, or revision'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor entry in this study, subjects must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study under the inclusion criteria listed below and received NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants Styles 410 FM, FF, MM, or MF in 1 (for unilateral breast reconstruction or revision) or both breasts.\n\n* Female, age 18 or older\n* Present with one or more of the following conditions:\n* Primary breast augmentation (i.e., no previous breast implant surgery) indicated for subject dissatisfaction, with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, or aplasia\n* Primary breast reconstruction (i.e., no previous breast implant surgery other than implantation of tissue expanders or contralateral augmentation for asymmetry) indicated, in the affected breast, for mastectomy for cancer, prophylactic mastectomy, or breast trauma (resulting in mastectomy) and for the unaffected breast, contralateral asymmetry (may be performed on the date of the mastectomy or the date when permanent implants are placed in the reconstructed breast)\n* Breast implant revision surgery (i.e., removal and replacement of breast implants) indicated for previous augmentation or reconstruction with silicone-filled or saline-filled breast implants\n* Has adequate tissue available to cover implants\n* Willing to undergo MRI at the specified follow-up visit for subjects at MRI designated sites and be eligible for MRI (e.g., no implanted metal or metal devices, no history of severe claustrophobia)\n\nExclusion Criteria:\n\nFor entry in this study, subjects must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study and met the exclusion criteria listed below but not received any NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled 410 X- or L-Style Breast Implants\n\n* Does not have advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy\n* Does not have existing carcinoma of the breast, without mastectomy\n* Does not have abscess or infection in the body at the time of enrollment\n* Is not pregnant or nursing\n* Does not have any disease, including uncontrolled diabetes (e.g., HbA1c \\> 8%), that is clinically known to impact wound healing ability\n* Does not show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity, or ulceration\n* Does not have or is under treatment for any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)\n* Does not show psychological characteristics that may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder)\n* Is not willing to undergo further surgery for revision, if medically required'}, 'identificationModule': {'nctId': 'NCT01853605', 'briefTitle': 'NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '410CA-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Augmentation', 'description': 'Women undergoing breast augmentation.', 'interventionNames': ['Device: Anatomically shaped silicone gel-filled breast implants']}, {'type': 'EXPERIMENTAL', 'label': 'Reconstruction', 'description': 'Women undergoing breast reconstruction.', 'interventionNames': ['Device: Anatomically shaped silicone gel-filled breast implants']}, {'type': 'EXPERIMENTAL', 'label': 'Revision-Augmentation', 'description': 'Women undergoing revision of previous breast augmentation.', 'interventionNames': ['Device: Anatomically shaped silicone gel-filled breast implants']}, {'type': 'EXPERIMENTAL', 'label': 'Revision-Reconstruction', 'description': 'Women undergoing revision of previous breast reconstruction.', 'interventionNames': ['Device: Anatomically shaped silicone gel-filled breast implants']}], 'interventions': [{'name': 'Anatomically shaped silicone gel-filled breast implants', 'type': 'DEVICE', 'otherNames': ['NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF)'], 'description': 'Surgical implant', 'armGroupLabels': ['Augmentation', 'Reconstruction', 'Revision-Augmentation', 'Revision-Reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan Medical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}