Clinical trial NCT03657069: Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy
Official title: A Pilot Study of Applying New Device Technologies for Tissue Expander/Implant-Based Breast Reconstruction (Blossom Syringe Assist Device)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Breast Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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:

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

Primary outcomes:
measure: Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved
timeFrame: Assessed weekly for up to 12 weeks
Secondary outcomes:
measure: BREAST-Q Reconstruction Module Version 2.0 Patient Satisfaction Score
timeFrame: Assessed weekly for up to 12 weeks
measure: Number of Participants With Major Complications Associated With Tissue Expansion Process
timeFrame: Assessed weekly for up to 12 weeks
measure: Number of Participants With Minor Complications Associated With Tissue Expansion Process
timeFrame: Assessed weekly for up to 12 weeks
measure: Number of Participants With Device Malfunction Associated With Tissue Expansion Process
timeFrame: Assessed weekly for up to 12 weeks
measure: Pain Score
timeFrame: Assessed weekly for up to 12 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Dung Nguyen
role: PRINCIPAL_INVESTIGATOR
References: