Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting
Completed · Not applicable
Conditions studied: Mammaplasty, Mastectomy, Lumpectomy
In brief
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.
Key facts
- Study ID
- NCT00466765
- Run by
- Brava
- People needed
- 589
- Starts
- 2010-01-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2015-05-05
Who can join
Age: 18 and older, up to 80. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Female volunteers between the ages of 18 and 80 years of age and weighing between 100- 275 lbs may be enrolled in the study. Ages 16 to 18 with developmental deformities may be enrolled with parental consent.
- Post implant removal with subcutaneous defect
- Post lumpectomy patients with or without radiation therapy with asymmetrical defect
- Post mastectomy with or without radiation therapy
- Post flap reconstruction with asymmetry or contour defect
- Primary breast augmentation
- Primary Post-mastectomy breast reconstruction
- Breast asymmetry
- Other congenital malformation of the breast such as constricted breasts, tubular breast, tuberous breasts, pectus associated deformities and Poland's Syndrome
You may not qualify if…
- The following volunteers must be excluded from the study:
- A volunteer who has a positive pregnancy test
- A volunteer who has a pacemaker or aneurysm clips
- A volunteer who has had a cardiac stent placed within the last two months
- A volunteer who is claustrophobic
- A volunteer with a known, current substance abuse
- A volunteer with a history of silicone allergy
- A volunteer with a history of Gadolinium allergy (if MRI performed)
- A volunteer with a history of Lidocaine allergy
- A volunteer with a bleeding diathesis
- Untreated breast cancer
- A volunteer who smokes cigarettes or who has a history of smoking within the past three (3) months.
- Medical Conditions including Sever Hypertension, Renal disease, steroid dependant asthma, immuno-suppressed disease, Systemic Lupus, uncontrolled diabetes
Where it is running
- Roger K Khouri, MD — Miami, Florida, United States
- Miami Breast Center, Medical Office of Roger Khouri MD — Miami, Florida, United States
Full record on ClinicalTrials.gov
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