NCT00466765

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 in autologous fat micro grafting breast augmentation and reconstruction procedures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
589

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
2.7 years until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 5, 2015

Status Verified

May 1, 2015

Enrollment Period

5.2 years

First QC Date

April 25, 2007

Last Update Submit

May 1, 2015

Conditions

MammaplastyMastectomyLumpectomy

Keywords

Fat GraftingBreast AugmentationLiposuctioned Fat TransferLumpectomyMastectomyMicromastiaAsymmetryPost Lumpectomy Filling DefectsPost implant removal filling defectPost MastectomyAutologous Fat TransferTubular breastsTuberous breastsConstricted breasts

Outcome Measures

Primary Outcomes (1)

  • Digital photographic interpretation by Board Certified Plastic Surgeon or Radiologist.

    6 months

Secondary Outcomes (1)

  • Patient's satisfaction with cosmetic and reconstructive result.

    1 year

Study Arms (1)

Single Arm

EXPERIMENTAL

Use Brava system for pre-expansion of breast prior to fat grafting

Device: Brava Autologous Fat Transfer System

Interventions

Brava Autologous Fat Transfer SystemDEVICE

Number of procedures is based on patient need

Also known as: Brava System
Single Arm

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Roger K Khouri, MD

Miami, Florida, 33134, United States

Location

Miami Breast Center, Medical Office of Roger Khouri MD

Miami, Florida, 33149, United States

Location

Related Publications (2)

  • Coleman SR, Saboeiro AP. Fat grafting to the breast revisited: safety and efficacy. Plast Reconstr Surg. 2007 Mar;119(3):775-85; discussion 786-7. doi: 10.1097/01.prs.0000252001.59162.c9.

    PMID: 17312477BACKGROUND

  • Rigotti G, Marchi A, Galie M, Baroni G, Benati D, Krampera M, Pasini A, Sbarbati A. Clinical treatment of radiotherapy tissue damage by lipoaspirate transplant: a healing process mediated by adipose-derived adult stem cells. Plast Reconstr Surg. 2007 Apr 15;119(5):1409-1422. doi: 10.1097/01.prs.0000256047.47909.71.

    PMID: 17415234BACKGROUND

Related Links

Study Officials

  • Roger K Khouri, MD

    Brava LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2007

First Posted

April 27, 2007

Study Start

January 1, 2010

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 5, 2015

Record last verified: 2015-05

Locations

US(2)