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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01702 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| BRS0088 | Other Identifier | OnCore |
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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.
PRIMARY OBJECTIVES:
I. To assess the clinical effectiveness of the application of Blossom Smart Expander Technology in 2-staged tissue expander/implant-based breast reconstruction.
SECONDARY OBJECTIVES:
I. Patient satisfaction. II. Patient self-reported pain. III. Incidence of complications.
OUTLINE:
After 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.
After completion of study treatment, participants are followed up at 1 week and then every week or every month thereafter for up to 12 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (Blossom Smart Expander Technology) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blossom | Device | Undergo Implant Breast Reconstruction (IBR) with the Blossom Smart Expander Technology |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved | 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. | Assessed weekly for up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| BREAST-Q Reconstruction Module Version 2.0 Patient Satisfaction Score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dung Nguyen | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Supportive Care (Blossom Smart Expander Technology) | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2017 |
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| Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire | Other | Ancillary studies |
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| Assessed weekly for up to 12 weeks |
| Number of Participants With Major Complications Associated With Tissue Expansion Process | 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. | Assessed weekly for up to 12 weeks |
| Number of Participants With Minor Complications Associated With Tissue Expansion Process | 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. | Assessed weekly for up to 12 weeks |
| Number of Participants With Device Malfunction Associated With Tissue Expansion Process | Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal. | Assessed weekly for up to 12 weeks |
| Pain Score | 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. | Assessed weekly for up to 12 weeks |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Supportive Care (Blossom Smart Expander Technology) | After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index (BMI) | Median | Inter-Quartile Range | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved | 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. | Posted | Median | Inter-Quartile Range | days | Assessed weekly for up to 12 weeks |
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| Secondary | BREAST-Q Reconstruction Module Version 2.0 Patient Satisfaction Score | 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed weekly for up to 12 weeks |
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| Secondary | Number of Participants With Major Complications Associated With Tissue Expansion Process | 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. | Posted | Count of Units | breasts | Assessed weekly for up to 12 weeks | breasts | breasts |
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| Secondary | Number of Participants With Minor Complications Associated With Tissue Expansion Process | 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. | Posted | Count of Units | breasts | Assessed weekly for up to 12 weeks | breasts | breasts |
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| Secondary | Number of Participants With Device Malfunction Associated With Tissue Expansion Process | Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal. | Posted | Count of Units | breasts | Assessed weekly for up to 12 weeks | breasts | breasts |
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| Secondary | Pain Score | 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed weekly for up to 12 weeks |
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Up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Supportive Care (Blossom Smart Expander Technology) | After mastectomy, participants undergo 2-staged IBR with the Blossom Smart Expander Technology. | 0 | 11 | 1 | 11 | 1 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment | Infection resulting TE removal |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seroma | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dung Nguyen, MD, PharmD, FACS | Stanford University | (650) 498-6004 | nguyendh@stanford.edu |
| Mar 30, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Hispanic |
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| breasts |
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| breasts |
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