Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting

NCT00466765 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 589

Last updated 2015-05-05

No results posted yet for this study

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.

Conditions

  • Mammaplasty
  • Mastectomy
  • Lumpectomy

Interventions

DEVICE

Brava Autologous Fat Transfer System

Number of procedures is based on patient need

Sponsors & Collaborators

  • Brava

    lead INDUSTRY

Principal Investigators

  • Roger K Khouri, MD · Brava LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00466765 on ClinicalTrials.gov