Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-25 @ 6:30 PM
Study NCT ID:
NCT03657069
Status:
COMPLETED
Last Update Posted:
2024-01-22
First Post:
2018-08-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nguyendh@stanford.edu', 'phone': '(650) 498-6004', 'title': 'Dung Nguyen, MD, PharmD, FACS', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Supportive Care (Blossom Smart Expander Technology)', 'description': 'After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Infection', 'notes': 'Infection resulting TE removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Blossom Smart Expander Technology)', 'description': 'After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '18'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed weekly for up to 12 weeks', 'description': 'Measured by calculating the number of days from expander placement to achievement of desired expansion volume. Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'BREAST-Q Reconstruction Module Version 2.0 Patient Satisfaction Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Blossom Smart Expander Technology)', 'description': 'After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '0.39', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed weekly for up to 12 weeks', 'description': 'Defined as patient satisfaction with expansion process. Score range: 1 to 5 (5=very satisfied, 4=somewhat satisfied, 3=neutral, 2=somewhat dissatisfied, 1=very dissatisfied). Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal. Scores were averaged to create an overall score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major Complications Associated With Tissue Expansion Process', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}, {'units': 'breasts', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Blossom Smart Expander Technology)', 'description': 'After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology.'}], 'classes': [{'title': 'Infection requiring IV antibiotics', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Infection resulting in TE removal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Any other issues requiring surgical intervention', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Assessed weekly for up to 12 weeks', 'description': 'Anticipated complications include Expander Extrusion, Wound Breakdown, and/or Infection. Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.', 'unitOfMeasure': 'breasts', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'breasts', 'denomUnitsSelected': 'breasts'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Minor Complications Associated With Tissue Expansion Process', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}, {'units': 'breasts', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Blossom Smart Expander Technology)', 'description': 'After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology.'}], 'classes': [{'title': 'Seroma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hematoma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Infection resolved with oral antibiotics', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Dehiscence, skin breakdown, etc.', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Assessed weekly for up to 12 weeks', 'description': 'Anticipated complications include Expander Extrusion, Wound Breakdown, and/or Infection. Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.', 'unitOfMeasure': 'breasts', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'breasts', 'denomUnitsSelected': 'breasts'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Device Malfunction Associated With Tissue Expansion Process', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}, {'units': 'breasts', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Blossom Smart Expander Technology)', 'description': 'After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Assessed weekly for up to 12 weeks', 'description': 'Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.', 'unitOfMeasure': 'breasts', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'breasts', 'denomUnitsSelected': 'breasts'}, {'type': 'SECONDARY', 'title': 'Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Blossom Smart Expander Technology)', 'description': 'After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.27', 'spread': '1.35', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed weekly for up to 12 weeks', 'description': 'Self-reported pain associated with expansion process. Patients will be asked to rank pain level on a scale of 0 to 10, with 0 being the least pain and 10 being the most pain. Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal. Scores were averaged to create an overall score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Supportive Care (Blossom Smart Expander Technology)', 'description': 'After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology comprised of the Blossom syringe assist device connected to the Mentor SPECTRUM adjustable saline breast implant.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '22', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '22', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'breasts'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Supportive Care (Blossom Smart Expander Technology)', 'description': 'After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000', 'lowerLimit': '35', 'upperLimit': '48'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'groupId': 'BG000', 'lowerLimit': '18.8', 'upperLimit': '24.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-18', 'size': 530628, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-30T13:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-18', 'studyFirstSubmitDate': '2018-08-30', 'resultsFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2018-08-30', 'lastUpdatePostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-18', 'studyFirstPostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved', 'timeFrame': 'Assessed weekly for up to 12 weeks', 'description': 'Measured by calculating the number of days from expander placement to achievement of desired expansion volume. Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.'}], 'secondaryOutcomes': [{'measure': 'BREAST-Q Reconstruction Module Version 2.0 Patient Satisfaction Score', 'timeFrame': 'Assessed weekly for up to 12 weeks', 'description': 'Defined as patient satisfaction with expansion process. Score range: 1 to 5 (5=very satisfied, 4=somewhat satisfied, 3=neutral, 2=somewhat dissatisfied, 1=very dissatisfied). Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal. Scores were averaged to create an overall score.'}, {'measure': 'Number of Participants With Major Complications Associated With Tissue Expansion Process', 'timeFrame': 'Assessed weekly for up to 12 weeks', 'description': 'Anticipated complications include Expander Extrusion, Wound Breakdown, and/or Infection. Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.'}, {'measure': 'Number of Participants With Minor Complications Associated With Tissue Expansion Process', 'timeFrame': 'Assessed weekly for up to 12 weeks', 'description': 'Anticipated complications include Expander Extrusion, Wound Breakdown, and/or Infection. Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.'}, {'measure': 'Number of Participants With Device Malfunction Associated With Tissue Expansion Process', 'timeFrame': 'Assessed weekly for up to 12 weeks', 'description': 'Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.'}, {'measure': 'Pain Score', 'timeFrame': 'Assessed weekly for up to 12 weeks', 'description': 'Self-reported pain associated with expansion process. Patients will be asked to rank pain level on a scale of 0 to 10, with 0 being the least pain and 10 being the most pain. Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal. Scores were averaged to create an overall score.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Carcinoma', 'Breast Disorder']}, 'descriptionModule': {'briefSummary': 'This phase 1 trial studies how well Blossom Smart Expander Technology works in breast reconstruction in participants with breast cancer undergoing mastectomy. Blossom Smart Expander Technology allows for slow and continuous injection of small amounts of saline, from an external pouch and based on precise pressure and volume measurements, into breast expander implants. It may help in achieving the same reconstructive goals as conventional tissue expansion in a shorter period of time and while avoiding frequent injections through the skin, which cause patient discomfort and require many clinic visits.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To assess the clinical effectiveness of the application of Blossom Smart Expander Technology in 2-staged tissue expander/implant-based breast reconstruction.\n\nSECONDARY OBJECTIVES:\n\nI. Patient satisfaction. II. Patient self-reported pain. III. Incidence of complications.\n\nOUTLINE:\n\nAfter mastectomy, participants undergo 2-staged implant-based breast reconstruction (IBR) with the Blossom Smart Expander Technology comprising of the Blossom syringe assist device connected to the Mentor SPECTRUM adjustable saline breast implant.\n\nAfter completion of study treatment, participants are followed up at 1 week and then every week or every month thereafter for up to 12 months'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of breast cancer or reason for prophylactic mastectomy (e.g., BRCA mutation and/or strong family history of breast cancer), both unilateral or bilateral mastectomy\n* No prior breast surgery (excluding biopsy and lumpectomy) or breast radiation\n* Ability to understand and the willingness to sign a written informed consent document\n* No life expectancy restrictions\n* Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will not be employed\n* No requirements for organ and marrow function\n\nExclusion Criteria:\n\n* Recent steroid use\n* No major medical comorbidities (defined as American Society of Anesthesiologists \\[ASA\\] III or greater)\n* No connective tissue disorder\n* Prior breast surgery, excluding biopsy and lumpectomy\n* History of or plan for breast radiation\n* Pregnancy and nursing patients will be excluded from the study\n* No restrictions regarding use of other investigational agents\n* No exclusion criteria related to history of allergic reactions\n* No exclusion criteria relating to concomitant medications or substances that have the potential to affect the activity or pharmacokinetics of the study agent\n* No other agent-specific exclusion criteria\n* No exclusion of cancer survivors or those who are human immunodeficiency virus (HIV)-positive'}, 'identificationModule': {'nctId': 'NCT03657069', 'briefTitle': 'Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Pilot Study of Applying New Device Technologies for Tissue Expander/Implant-Based Breast Reconstruction (Blossom Syringe Assist Device)', 'orgStudyIdInfo': {'id': 'IRB-44367'}, 'secondaryIdInfos': [{'id': 'NCI-2018-01702', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'BRS0088', 'type': 'OTHER', 'domain': 'OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive care (Blossom Smart Expander Technology)', 'description': 'After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology comprising of the Blossom syringe assist device connected to the Mentor SPECTRUM adjustable saline breast implant.', 'interventionNames': ['Device: Blossom', 'Other: Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire']}], 'interventions': [{'name': 'Blossom', 'type': 'DEVICE', 'otherNames': ['Blossom Smart Expander Technology (Syringe Assist Device)'], 'description': 'Undergo Implant Breast Reconstruction (IBR) with the Blossom Smart Expander Technology', 'armGroupLabels': ['Supportive care (Blossom Smart Expander Technology)']}, {'name': 'Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (Blossom Smart Expander Technology)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Dung Nguyen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Dung Nguyen', 'investigatorAffiliation': 'Stanford University'}}}}