Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting

This study has been completed.
Information provided by (Responsible Party):
Brava Identifier:
First received: April 25, 2007
Last updated: May 1, 2015
Last verified: May 2015
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
Device: Brava Autologous Fat Transfer System

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 ]

Enrollment: 589
Study Start Date: January 2010
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm
Use Brava system for pre-expansion of breast prior to fat grafting
Device: Brava Autologous Fat Transfer System
Number of procedures is based on patient need
Other Name: Brava System

  Show Detailed Description


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.

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00466765

United States, Florida
Miami Breast Center, Medical Office of Roger Khouri MD
Miami, Florida, United States, 33149
Roger K Khouri, MD
Miami, Florida, United States, 33134
Sponsors and Collaborators
Principal Investigator: Roger K Khouri, MD Brava LLC
  More Information

Additional Information:
Responsible Party: Brava Identifier: NCT00466765     History of Changes
Other Study ID Numbers: Protocol no. 2004-03
Study First Received: April 25, 2007
Last Updated: May 1, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Brava:
Fat Grafting
Breast Augmentation
Liposuctioned Fat Transfer
Post Lumpectomy Filling Defects
Post implant removal filling defect
Post Mastectomy
Autologous Fat Transfer
Tubular breasts
Tuberous breasts
Constricted breasts processed this record on November 24, 2015