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Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Brava
ClinicalTrials.gov Identifier:
NCT00466765
First received: April 25, 2007
Last updated: May 6, 2014
Last verified: May 2014
  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: May 2015
Estimated Primary Completion Date: May 2015 (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
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 ClinicalTrials.gov identifier: NCT00466765

Locations
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
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 6, 2014
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 November 20, 2014