Trial Search Results

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Device: Blossom
  • Other: Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire

Phase:

N/A

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shannon Meyer
650-724-1953
Recruiting