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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Carcinoma; Breast Disorder
• Intervention / Treatment: Device: Blossom; Other: Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire

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

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Stanford University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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	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.	Assessed weekly for up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BREAST-Q Reconstruction Module Version 2.0 Patient Satisfaction Score	Defined as patient satisfaction with expansion process. Score range: 1 to 5 (5=very satisfied, 4=somewhat satisfied, 3=neutral, 2=somewhat dissatisfied, 1=very dissatisfied). Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal. Scores were averaged to create an overall score.	Assessed weekly for up to 12 weeks
Number of Participants With Major Complications Associated With Tissue Expansion Process	Anticipated complications include Expander Extrusion, Wound Breakdown, and/or Infection. Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.	Assessed weekly for up to 12 weeks
Number of Participants With Minor Complications Associated With Tissue Expansion Process	Anticipated complications include Expander Extrusion, Wound Breakdown, and/or Infection. Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.	Assessed weekly for up to 12 weeks
Number of Participants With Device Malfunction Associated With Tissue Expansion Process	Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.	Assessed weekly for up to 12 weeks
Pain Score	Self-reported pain associated with expansion process. Patients will be asked to rank pain level on a scale of 0 to 10, with 0 being the least pain and 10 being the most pain. Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal. Scores were averaged to create an overall score.	Assessed weekly for up to 12 weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Dung Nguyen, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): August 19, 2020
• Study Completion (Actual): August 19, 2020

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IRB-44367; NCI-2018-01702 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); BRS0088 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No