Actively Recruiting
Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
Led by Stanford University · Updated on 2025-11-17
20
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
M
Marz Medical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The conventional breast tissue expander used for breast reconstruction/ augmentation requires weekly or biweekly injections of saline through the skin and into an integrated port in the implant using a needle and syringe in order to expand breast skin, which is an in-office procedure and can be uncomfortable for patients. Blossom Smart Expander Technology, currently available on the market, aims to achieve the same tissue expansion while avoiding frequent injections through the skin by means of an expansion device that slowly and continuously injects a very small amount of saline. Expansion of the device is based on pressure and volume in the expander, allowing for a tailored expansion process for individual patients' physiology. The purpose of this study is to assess the clinical effectiveness of Blossom Smart Expander Technology in 2-staged tissue expander/implant-based breast reconstruction/ augmentation compared to standard tissue expansion methods.
CONDITIONS
Official Title
Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women ages 18 or older
- Pursuing non-oncologic breast reconstruction or augmentation
- Willing and able to understand and sign an English informed consent form
- Desire for two-stage tissue expander and implant-based breast reconstruction or augmentation
You will not qualify if you...
- Active breast cancer
- Recent steroid use
- Major medical comorbidities classified as ASA III or greater
- Connective tissue disorder
- Pregnant or nursing
- Unable to understand or sign English consent forms
- Older than 65 years
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Stanford Hospital and Clinics
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
D
Dung H Nguyen, MD, PharmD
CONTACT
E
Elizabeth Tadevosyan, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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