Clinical Research Directory
Browse clinical research sites, groups, and studies.
Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
Sponsor: Stanford University
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2023-11-17
Completion Date
2026-07
Last Updated
2025-11-17
Healthy Volunteers
Yes
Interventions
Blossom tissue expander
Mentor spectrum adjustable saline breast implant for expansion is placed with the Blossom tissue expander above pectoralis major during first stage surgery of an implant-based breast reconstruction/ augmentation.
Standard tissue expansion
Mentor spectrum adjustable saline breast implant for expansion is placed with (without the Blossom tissue expander) above pectoralis major during first stage surgery of an implant-based breast reconstruction/ augmentation.
Locations (1)
Stanford Hospital and Clinics
Palo Alto, California, United States