Breast Cancer Clinical Trial
Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy
Summary
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.
Full Description
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
Eligibility Criteria
Inclusion Criteria:
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
No prior breast surgery (excluding biopsy and lumpectomy) or breast radiation
Ability to understand and the willingness to sign a written informed consent document
No life expectancy restrictions
Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will not be employed
No requirements for organ and marrow function
Exclusion Criteria:
Recent steroid use
No major medical comorbidities (defined as American Society of Anesthesiologists [ASA] III or greater)
No connective tissue disorder
Prior breast surgery, excluding biopsy and lumpectomy
History of or plan for breast radiation
Pregnancy and nursing patients will be excluded from the study
No restrictions regarding use of other investigational agents
No exclusion criteria related to history of allergic reactions
No exclusion criteria relating to concomitant medications or substances that have the potential to affect the activity or pharmacokinetics of the study agent
No other agent-specific exclusion criteria
No exclusion of cancer survivors or those who are human immunodeficiency virus (HIV)-positive
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There is 1 Location for this study
Stanford California, 94304, United States More Info
Principal Investigator
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