N/A
N=11
Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy
Breast Carcinoma · Breast Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03657069 ↗Enrolled (actual)
11
Serious AEs
9.1%
Results posted
Jan 2024
Primary outcome: Primary: Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved — 13 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blossom (Device); Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved |
13 | — |
| SECONDARY BREAST-Q Reconstruction Module Version 2.0 Patient Satisfaction Score |
4.8 | — |
| SECONDARY Number of Participants With Major Complications Associated With Tissue Expansion Process |
0; 1; 0 | — |
| SECONDARY Number of Participants With Minor Complications Associated With Tissue Expansion Process |
1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Device Malfunction Associated With Tissue Expansion Process |
— | — |
| SECONDARY Pain Score |
1.27 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03657069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.