Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT01964105
Status:
COMPLETED
Last Update Posted:
2017-12-26
First Post:
2013-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D021621', 'term': 'Imaging, Three-Dimensional'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'myckatyn@wustl.edu', 'phone': '314-362-4263', 'title': 'TERENCE MICHAEL MYCKATYN, PI, PROFESSOR, PLASTIC SURGERY', 'organization': 'WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, SAINT LOUIS'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months (entire study period)', 'description': 'Adverse events were collected as defined by clinicaltrials.gov', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Preoperative Evaluation', 'description': 'Patients undergo standard tissue-based planning. They were randomized to this intervention.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '3D Imaging Simulation', 'description': 'Patient undergo three-dimensional simulation of their breast augmentation. They were randomized to this intervention.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Non-Randomized Cohort: 3D Imaging', 'description': 'Patient undergo three-dimensional simulation of their breast augmentation. They sought this intervention (ie. not randomized).', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Breast Q Augmentation Module', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Preoperative Evaluation', 'description': 'Intervention Group: 3D Image Simulation + Standard Preoperative Evaluation Goal: 50 patients\n\n3D Imaging'}, {'id': 'OG001', 'title': '3D Imaging Simulation', 'description': 'Control Group: Patients will receive standard preoperative evaluation (2D imaging).\n\nGoal: 50 patients'}, {'id': 'OG002', 'title': 'Non-Randomized Cohort: 3D Imaging', 'description': 'Patients who refuse the option of randomization but otherwise meet the inclusion and exclusion criteria will be offered participation in this study as part of a non-randomized cohort.\n\nGoal: 50 Patients\n\n3D Imaging'}], 'classes': [{'categories': [{'measurements': [{'value': '494.5', 'spread': '93', 'groupId': 'OG000'}, {'value': '503.4', 'spread': '113.1', 'groupId': 'OG001'}, {'value': '420', 'spread': '119.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 6 months postop visit.', 'description': 'BREAST-Q is a validated measures of patient reported outcomes (this is not an acronym). For this study we utilized the preoperative and postoperative BREAST -Q designed to analyze outcomes following breast augmentation The BREAST-Q is measured as a Q-score on a scale of 0-100. 0 is a poor score, 100 is an optimal score. Q-scores stand independently and are not combined to create a total score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Preoperative Evaluation', 'description': 'Control Group: Patients will receive standard preoperative evaluation (2D imaging).\n\nGoal: 50 patients'}, {'id': 'FG001', 'title': 'Non-Randomized Cohort: 3D Imaging', 'description': 'Patients who refuse the option of randomization but otherwise meet the inclusion and exclusion criteria will be offered participation in this study as part of a non-randomized cohort.\n\nGoal: 50 Patients\n\n3D Imaging'}, {'id': 'FG002', 'title': '3D Imaging Simulation', 'description': 'Intervention Group: 3D Image Simulation + Standard Preoperative Evaluation Goal: 50 patients\n\n3D Imaging'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '3D Imaging Simulation', 'description': 'The intervention group underwent computer simulation with the Vectra Sculptor package (Canfield Scientific Inc, Parsippany, NJ) in addition to control group preoperative evaluation.'}, {'id': 'BG001', 'title': 'Standard Preoperative Evaluation', 'description': 'The control group underwent tissue-based planning that was supplemented by review of photos obtained from magazines or the internet, and placement of sizers in a surgical bra. Control group patients underwent three-dimensional photography with the same system but were not simulated.'}, {'id': 'BG002', 'title': 'Non-Randomized Cohort: 3D Imaging', 'description': 'Since enrollment in the non-randomized arm was predicated upon a pre-existing desire for computer simulation, all of these patients received this intervention.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '38.3', 'spread': '23.1', 'groupId': 'BG000'}, {'value': '40.2', 'spread': '11', 'groupId': 'BG001'}, {'value': '35.8', 'spread': '8.2', 'groupId': 'BG002'}, {'value': '37.2', 'spread': '8.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Volume of Breast', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '494.5', 'spread': '93', 'groupId': 'BG000'}, {'value': '503.4', 'spread': '113.1', 'groupId': 'BG001'}, {'value': '420', 'spread': '119.3', 'groupId': 'BG002'}, {'value': '441', 'spread': '120.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cubic centimeters (cc)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BREAST-Q', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '63.6', 'spread': '18.6', 'groupId': 'BG000'}, {'value': '70.1', 'spread': '21.5', 'groupId': 'BG001'}, {'value': '64.8', 'spread': '19.3', 'groupId': 'BG002'}, {'value': '64.6', 'spread': '19.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'BREAST-Q is a validated measures of patient reported outcomes. For this study we utilized the preoperative and postoperative BREAST -Q designed to analyze outcomes following breast augmentation The BREAST-Q is measured as a Q-score on a scale of 0-100. 0 is a poor score, 100 is an optimal score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All patients presenting for primary breast augmentation that were not excluded. We excluded patients who refused participation in a study, cancelled surgery, had greater than grade I ptosis, congenital deformity of the chest wall, could not commit to 6 months follow-up, needed a concurrent mastopexy, or had concomitant fat transfer to the breast.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-08-27', 'size': 287520, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-10-04T19:21', 'hasProtocol': True}, {'date': '2017-04-27', 'size': 292750, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2017-10-04T19:21', 'hasProtocol': False}, {'date': '2014-08-27', 'size': 63336, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2017-10-31T18:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-29', 'studyFirstSubmitDate': '2013-09-26', 'resultsFirstSubmitDate': '2017-10-05', 'studyFirstSubmitQcDate': '2013-10-16', 'lastUpdatePostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-29', 'studyFirstPostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breast Q Augmentation Module', 'timeFrame': 'up to 6 months postop visit.', 'description': 'BREAST-Q is a validated measures of patient reported outcomes (this is not an acronym). For this study we utilized the preoperative and postoperative BREAST -Q designed to analyze outcomes following breast augmentation The BREAST-Q is measured as a Q-score on a scale of 0-100. 0 is a poor score, 100 is an optimal score. Q-scores stand independently and are not combined to create a total score.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypomastia', 'Augmentation', 'Breast', '3D', 'Breast Q'], 'conditions': ['Hypomastia', 'Primary Breast Augmentation']}, 'referencesModule': {'references': [{'pmid': '20048631', 'type': 'BACKGROUND', 'citation': 'Tepper OM, Unger JG, Small KH, Feldman D, Kumar N, Choi M, Karp NS. Mammometrics: the standardization of aesthetic and reconstructive breast surgery. Plast Reconstr Surg. 2010 Jan;125(1):393-400. doi: 10.1097/PRS.0b013e3181c4966e. No abstract available.'}, {'pmid': '19644246', 'type': 'BACKGROUND', 'citation': 'Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.'}, {'pmid': '30045174', 'type': 'DERIVED', 'citation': 'Overschmidt B, Qureshi AA, Parikh RP, Yan Y, Tenenbaum MM, Myckatyn TM. A Prospective Evaluation of Three-Dimensional Image Simulation: Patient-Reported Outcomes and Mammometrics in Primary Breast Augmentation. Plast Reconstr Surg. 2018 Aug;142(2):133e-144e. doi: 10.1097/PRS.0000000000004601.'}], 'seeAlsoLinks': [{'url': 'http://westcountyplasticsurgeons.wustl.edu/', 'label': "Click here for Washington University's study location."}]}, 'descriptionModule': {'briefSummary': "The purpose of this trial is to evaluate the impact of incorporating three-dimensional (3D)imaging during preoperative consultation on patient reported outcomes in primary breast augmentation surgery. 3D imaging is an innovative technology that allows the surgeon to share with images how one could look after one's procedure. The patient's assessment will be collected using the Breast Q, an objective questionnaire that captures patient satisfaction with breast augmentation.", 'detailedDescription': 'Consultation for primary breast augmentation involves clear communication between patient and surgeon to select the implant and manage expectations. Tissue-based planning strategies rely on tissue characteristics and measurements to produce safe and reproducible aesthetic outcomes. The implementation of sizers in the preoperative consultation and a greater emphasis on patient aesthetic goals have also proven to be favorable strategies. Recently, many plastic surgeons have started to incorporate three-dimensional (3D) photography and computer simulation into their preoperative consultation process. The accuracy of computer simulation for volume assessment of breast augmentation is reportedly ≥90%, and patients demonstrate a preference for consultations involving simulation.Support for computer simulation, however, is not unanimous.\n\nQuantitative analyses, prospective study designs, and utilization of validated health-related quality of life metrics have been recommended to more thoroughly scrutinize implant selection systems and outcomes in aesthetic surgery.Mammometrics yields numerical data useful for quantifying changes in breast morphology after breast reduction, reconstruction with implants, and augmentation. The BREAST-Q represents the most comprehensive and quantitative method for patient self-assessment following breast surgery, and has gained traction as a patient-reported outcomes instrument for breast augmentation. To date, there are no studies that focus on the impact of simulation on patient-reported outcomes in breast augmentation, as measured with the validated BREAST-Q. Furthermore, there is minimal data examining correlations between patient-reported outcomes and mammometrics.\n\nThe purpose of this study was to conduct a prospective, clinical trial to evaluate the impact of 3D imaging and simulation used during the preoperative consultation on postoperative patient-reported outcomes and quantitative changes in breast morphology. We hypothesized that computer simulation would facilitate patient education and surgical planning, thus leading to quantitatively higher patient-reported outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Scheduled for elective breast augmentation cosmetic procedure.\n\nExclusion Criteria:\n\n* Breast reconstruction for malignancy\n* Cognitively unable to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT01964105', 'briefTitle': '3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': '3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery: Does 3D Improve Patient Reported Outcomes in Primary Breast Augmentation?', 'orgStudyIdInfo': {'id': '201210065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D Imaging Simulation', 'description': 'Intervention Group: 3D Image Simulation + Standard Preoperative Evaluation Goal: 50 patients', 'interventionNames': ['Device: 3D Imaging']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Preoperative Evaluation', 'description': 'Control Group: Patients will receive standard preoperative evaluation (2D imaging).\n\nGoal: 50 patients'}, {'type': 'OTHER', 'label': 'Non-Randomized Cohort: 3D Imaging', 'description': 'Patients who refuse the option of randomization but otherwise meet the inclusion and exclusion criteria will be offered participation in this study as part of a non-randomized cohort.\n\nGoal: 50 Patients', 'interventionNames': ['Device: 3D Imaging']}], 'interventions': [{'name': '3D Imaging', 'type': 'DEVICE', 'otherNames': ['Vectra 3D'], 'armGroupLabels': ['3D Imaging Simulation', 'Non-Randomized Cohort: 3D Imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'West County Plastic Surgeons of Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Terence M Myckatyn, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}