Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting
NCT00466765 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 589
Last updated 2015-05-05
Summary
The primary objectives of this study is to determine whether use of a negative pressure external soft-tissue expansion system pre-operatively and post-operatively improves and secures graft survival in autologous fat micro grafting breast augmentation and reconstruction procedures.
Conditions
- Mammaplasty
- Mastectomy
- Lumpectomy
Interventions
- DEVICE
-
Brava Autologous Fat Transfer System
Number of procedures is based on patient need
Sponsors & Collaborators
-
Brava
lead INDUSTRY
Principal Investigators
-
Roger K Khouri, MD · Brava LLC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-01-31
- Primary Completion
- 2015-04-30
- Completion
- 2015-04-30
Countries
- United States
Study Locations
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