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

Trial ID or NCT#

NCT03657069

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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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Investigator(s)

Dung Nguyen
Dung Nguyen
Breast reconstructive surgeon, Plastic and reconstructive surgeon, Chest reconstructive surgeon
Clinical Professor, Surgery - Plastic & Reconstructive Surgery

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Contact

Shannon Meyer
650-724-1953

View on ClinicalTrials.gov