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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
11
Undergo Implant Breast Reconstruction (IBR) with the Blossom Smart Expander Technology
Stanford University Medical Center
Stanford, California, United States
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.
Time frame: Assessed weekly for up to 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed weekly for up to 12 weeks
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