Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
Recruiting
N/A
Interventional Study
Tissue Expansion
Implant Based Breast Reconstruction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 20 (estimated)
- Sponsor
- Stanford University · Other
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About This Trial
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 t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Women ages 18 or older; pursuing non-oncologic breast reconstruction or augmentation; and ability to understand and the willingness to sign a written informed consent document (english language). Only patients desiring 2-staged tissue expander/ implant-based breast reconstruct…
Contacts