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

Stanford University

Status: Completed

Conditions: Breast Disorder; Breast Carcinoma

Treatments: Other: Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire; Device: Blossom

Study type: Interventional

Funder types: Other

Identifiers

NCT03657069

NCI-2018-01702 (Registry Identifier)

IRB-44367

BRS0088 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 11 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Supportive care (Blossom Smart Expander Technology)

Experimental group

Description:

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.

Treatment:

Other: Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire

Device: Blossom