Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting
This study is currently recruiting participants.
Verified May 2013 by Brava
Sponsor:
Brava
Information provided by (Responsible Party):
Brava
ClinicalTrials.gov Identifier:
NCT00466765
First received: April 25, 2007
Last updated: May 9, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Mammaplasty Mastectomy Lumpectomy |
Procedure: Autologous Fat Grafting to the Breast |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting |
Resource links provided by NLM:
Further study details as provided by Brava:
Primary Outcome Measures:
- Digital photographic interpretation by Board Certified Plastic Surgeon or Radiologist. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Patient's satisfaction with cosmetic and reconstructive result. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 682 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Single Arm
Brava Expansion and Fat Grafting
|
Procedure: Autologous Fat Grafting to the Breast
Number of procedures is based on patient need
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
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 Criteria:
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00466765
Contacts
| Contact: Roger K Khouri, MD | 305-365-5595 | Rogerkkhouri@aol.com |
| Contact: Roger K Khouri, MD | 305-365-5595 | info@miamibreastcenter.com |
Locations
| United States, Florida | |
| Miami Breast Center, Medical Office of Roger Khouri MD | Recruiting |
| Miami, Florida, United States, 33149 | |
| Contact: Roger K Khouri, MD 305-365-5595 info@miamibreastcenter.com | |
| Principal Investigator: Roger K Khouri, MD | |
| Roger K Khouri, MD | Recruiting |
| Miami, Florida, United States, 33134 | |
| Contact: Roger K Khouri, MD 305-642-4263 rogerkkhouri@aol.com | |
| Principal Investigator: Roger K Khouri, MD | |
Sponsors and Collaborators
Brava
Investigators
| Principal Investigator: | Roger K Khouri, MD | Brava LLC |
More Information
Additional Information:
Publications:
| Responsible Party: | Brava |
| ClinicalTrials.gov Identifier: | NCT00466765 History of Changes |
| Other Study ID Numbers: | Protocol no. 2004-03 |
| Study First Received: | April 25, 2007 |
| Last Updated: | May 9, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Brava:
|
Fat Grafting Breast Augmentation Liposuctioned Fat Transfer Lumpectomy Mastectomy Micromastia Asymmetry |
Post Lumpectomy Filling Defects Post implant removal filling defect Post Mastectomy Autologous Fat Transfer Tubular breasts Tuberous breasts Constricted breasts |
ClinicalTrials.gov processed this record on May 23, 2013