Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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A Pilot Study of Applying New Device Technologies for Tissue Expander/Implant-Based Breast Reconstruction (Blossom Syringe Assist Device)

Conditions
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Breast Carcinoma, Breast Disorder

Intervention / Treatment
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* Device: Blossom
* Other: Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (Blossom Smart Expander Technology)<br>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. | Device: Blossom<br>* Undergo Implant Breast Reconstruction (IBR) with the Blossom Smart Expander Technology<br>* Other names: Blossom Smart Expander Technology (Syringe Assist Device);Other: Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to full expansion defined as number of days until desired breast tissue expansion volume is achieved | Will be measured by calculating the number of days from expander placement to achievement of desired expansion volume. Measurement time points include date of expander placement and date that desired expansion volume is reached. The primary outcome values will be compared to values commonly reported in the literature in conventional 2-staged implant-based breast reconstruction (IBR). | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction defined as patient satisfaction with expansion process | Will be measured by non-validated surveys (Breast questionnaire [Q]- Reconstruction module (preoperative) Version 2.0) administered to patients in clinic in order to assess satisfaction. Patients will be asked to rank satisfaction on the following scale: very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, very dissatisfied. Measurement time points will be at postoperative clinic visits, which will occur at weekly and intervals during the expansion process. Survey data will be tabulated. | Up to 12 months | 
| Incidence of complications defined as complications associated with tissue expansion process, including expander extrusion, wound breakdown, infection, and/or device malfunction | Will be measured by assessment of these patients at postoperative clinic visits for these complications. Measurement time points will be at postoperative clinic visits, which will occur at weekly intervals during the expansion process. The data will be compared to values commonly reported in the literature in conventional 2-staged implant-based breast reconstruction (IBR). | Up to 12 months | 
| Pain with expansion defined as self-reported pain associated with expansion process | Will be measured by non-validated surveys (Breast Q) administered to patients in clinic in order to assess pain. Patients will be asked to rank pain level on a scale of 0 to 10, with 0 being the least and 10 being the most. Measurement time points will be at postoperative clinic visits, which will occur at weekly intervals during the expansion process. Survey data will be tabulated. | Up to 12 months |