Skip to main content
OpenTrials
Completed

NCT Number: NCT03657069

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Carcinoma Breast Diseases Breast Disorder Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University Medical Center

Stanford, California, 94304, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blossom

Device

Undergo Implant Breast Reconstruction (IBR) with the Blossom Smart Expander Technology

Other names: Blossom Smart Expander Technology (Syringe Assist Device)

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

Other

Ancillary studies

Primary outcomes

  1. Time to Full Expansion Defined as Number of Days Until Desired Breast Tissue Expansion Volume is Achieved

    Time frame: 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 outcomes

  1. BREAST-Q Reconstruction Module Version 2.0 Patient Satisfaction Score

    Time frame: 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.

  2. Number of Participants With Major Complications Associated With Tissue Expansion Process

    Time frame: 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.

  3. Number of Participants With Minor Complications Associated With Tissue Expansion Process

    Time frame: 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.

  4. Number of Participants With Device Malfunction Associated With Tissue Expansion Process

    Time frame: 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.

  5. Pain Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 4, 2018
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.