NCT00663156

Brief Summary

This research study is to evaluate the natural history of fat transplanted from a person's body to their breasts. We are seeking a natural, safe, and effective alternative to breast implants. Patients will undergo liposuction of their body followed by infiltration of this harvested fat around their breasts. The study protocol will involve preoperative and postoperative photographs, mammograms, and MRI to look for changes in the breast shape and size, as well as any internal changes in the breast tissue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

4.8 years

First QC Date

April 1, 2008

Last Update Submit

February 14, 2013

Conditions

Breast AugmentationFat Grafting

Keywords

lipoaugmentationbreast augmentationfat graftingliposuctionlipoinfiltrationSpearbreast implantsASERFLipivageBakerharvestautologousGeorgetown

Outcome Measures

Primary Outcomes (1)

  • Effectiveness will be evaluated by comparing breast volume pre-operatively and at 1 year post-operatively using 3-dimensional picture imaging to obtain objective volume measurements.

    One year post-op

Secondary Outcomes (1)

  • Patients will be evaluated by mammogram, MRI, and 3-D photography to monitor for breast tissue abnormalities and measure increase in volume

    one year

Study Arms (2)

subject

EXPERIMENTAL

10 subjects receiving breast augmentation with fat grafting

Procedure: Liposuction, fat grafting

control

OTHER

10 control will have breast augmentation using breast implants

Procedure: breast implants

Interventions

breast implantsPROCEDURE

patients will have breast augmentation using implants

Also known as: Allergan, Mentor
control
Liposuction, fat graftingPROCEDURE

Autologous fat will be harvested from the body (typically the abdomen or thighs) using syringe aspiration techniques and then infiltrated into the subcutaneous tissue around the breast as well as between the breast and the underlying musculature using blunt cannulas. These procedures will be done in an outpatient surgery setting in the Georgetown University Hospital under general anesthesia and sterile conditions.

Also known as: Lipovage, Vectra 3-D
subject

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • willing to have mammogram, MRI, and photographs
  • willing to follow study requirements and sign informed consent
  • no previous breast surgeries
  • must reside within 50 miles of the Washington, D.C. Metropolitan area

You may not qualify if:

  • pregnant or nursing
  • existing breast cancer
  • advanced fibrocystic disease
  • protease inhibitors
  • any condition leading to surgical risk
  • any disease known to affect wound healing
  • abscess or infection in the body
  • incompatible psychological factors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Interventions

Breast ImplantsIdoxuridineLipectomy

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and SuppliesDeoxyuridineUridinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCosmetic TechniquesTherapeuticsBariatric SurgeryBariatricsObesity ManagementSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Scott L Spear, MD

    Georgetown University hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Plastic Surgery

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 22, 2008

Study Start

March 1, 2008

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

US(1)