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

Not Applicable

Completed

• Conditions: Breast Carcinoma; Breast Disorder
• Interventions: Device: Blossom; Other: Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire

• Registration Number: NCT03657069
• Lead Sponsor: Stanford University

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

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-08-30
• Study First Posted: 2018-09-04
• Primary Completion: 2020-08-19
• Study Completion: 2020-08-19
• Status Verified: 2023-04
• Results First Submitted: 2023-04-18
• Results First Submitted QC: 2023-04-18
• Last Update Submitted: 2023-04-18
• Results First Posted: 2024-01-22
• Last Update Posted: 2024-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (Blossom Smart Expander Technology)	Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire	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.
Supportive care (Blossom Smart Expander Technology)	Blossom	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.

Primary Outcome Measures

Name	Time	Method
Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved	Assessed weekly for up to 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Device Malfunction Associated With Tissue Expansion Process	Assessed weekly for up to 12 weeks	Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.
Pain Score	Assessed weekly for up to 12 weeks	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.
BREAST-Q Reconstruction Module Version 2.0 Patient Satisfaction Score	Assessed weekly for up to 12 weeks	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.
Number of Participants With Major Complications Associated With Tissue Expansion Process	Assessed weekly for up to 12 weeks	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.
Number of Participants With Minor Complications Associated With Tissue Expansion Process	Assessed weekly for up to 12 weeks	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.

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States