Status:
COMPLETED
Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting
Lead Sponsor:
Brava
Conditions:
Mammaplasty
Mastectomy
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief 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 i...
Detailed Description
Procedure: Urine pregnancy test will be performed before each designated procedure in the study. Patients will be questioned about underlying renal disease and excluded if existent. Pre-operative/ba...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
589 Patients enrolled
Trial Details
Trial ID
NCT00466765
Start Date
January 1 2010
End Date
April 1 2015
Last Update
May 5 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Roger K Khouri, MD
Miami, Florida, United States, 33134
2
Miami Breast Center, Medical Office of Roger Khouri MD
Miami, Florida, United States, 33149