|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Brava |
|---|---|
| Information provided by (Responsible Party): | Brava |
| ClinicalTrials.gov Identifier: | NCT00466765 |
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: | Allocation: Non-Randomized 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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2004 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (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 |
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.
Exclusion Criteria:
The following volunteers must be excluded from the study:
Contacts and Locations| Contact: Roger K Khouri, MD | 305-365-5595 | Rogerkkhouri@aol.com |
| Contact: Roger K Khouri, MD | 305-365-5595 | info@miamibreastcenter.com |
| 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 | |
| Principal Investigator: | Roger K Khouri, MD | Brava LLC |
More Information
| 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: | November 11, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
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 |