A Pilot Study of Applying New Device Technologies for Tissue Expander/Implant-Based Breast Reconstruction (Blossom Syringe Assist Device)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 11
- Locations
- 2
- Primary Endpoint
- Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved
Study Overview
Brief 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.
Detailed 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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved
Time Frame: Assessed weekly for up to 12 weeks
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.
Secondary Outcomes
- Number of Participants With Device Malfunction Associated With Tissue Expansion Process(Assessed weekly for up to 12 weeks)
- Pain Score(Assessed weekly for up to 12 weeks)
- BREAST-Q Reconstruction Module Version 2.0 Patient Satisfaction Score(Assessed weekly for up to 12 weeks)
- Number of Participants With Major Complications Associated With Tissue Expansion Process(Assessed weekly for up to 12 weeks)
- Number of Participants With Minor Complications Associated With Tissue Expansion Process(Assessed weekly for up to 12 weeks)
Investigators
Dung Nguyen
Clinical Professor
Stanford University