VASER-Assisted Lipoplasty Compared With Suction-Assisted Lipoplasty (Contra-Lateral)

June 6, 2011 updated by: Sound Surgical Technologies, LLC.

A Multi-Center, Prospective, Randomized, Single-Blind, Controlled Clinical Trial Comparing VASER-Assisted Lipoplasty and Suction-Assisted Lipoplasty.

This study is being done to compare two commonly available types of body contouring, VASER-Assisted Lipoplasty (VAL) and Suction-Assisted Lipoplasty (SAL), and to decide if one procedure is preferred by patients and/or surgeons over the other. Participants will have VAL on one side of their body and SAL on the opposite side.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

21

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33146
        • Plastic Surgery Center of South Florida
    • New Jersey
      • Toms River, New Jersey, United States, 08753
        • Personal Enhancement Center
    • Ohio
      • Mentor, Ohio, United States, 44060
        • Paul F. Vanek, M.D., F.A.C.S.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • give voluntary, signed informed consent in accordance with institutional policies
  • be between the ages of 18-50 years old
  • Be willing and able to appear for all scheduled, post-operative visits with their doctor
  • Have moderate to good skin tone
  • Have excess fatty tissue in the arms, medial thighs, lateral thighs, or back where the extra tissue is expected to be composed of adipose tissue.
  • Have a body mass index between 20-30
  • Are non-smokers

Exclusion Criteria:

  • under the age of 18
  • over the age of 50
  • are undergoing boy contouring for reconstruction following injury or disease are deemed inappropriate candidates for surgery due to medical or mental health reasons
  • are concurrently being treated with other investigational agents or have participated in an investigational study within 60 days prior to surgery
  • elect not to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: SAL
Each patient will have Suction Assisted Lipoplasty procedure on one side of the body (this will be considered the control side)
Device: Suction-assisted Lipoplasty
Standard Suction-assisted lipoplasty will be performed on one side of the body to remove excess fat and contour the body in one or more of the following body areas: arm, inner thigh, outer thigh, back
Other Names:
  • Suction-assisted lipoplasty, Liposuction
ACTIVE_COMPARATOR: VAL
Each patient will have VASER- assisted lipoplasty on the opposite side of the body. This will be the comparison side.
Device: VASER-assisted lipoplasty
VASER-assisted lipoplasty will be performed on the opposite side of the body to remove excess fat and contour the body in one or more of the following body areas: arm, inner thigh, outer thigh, back
Other Names:
  • VAL, VASER, LipoSelection, 3rd Generation UAL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Investigators aim to assess outcomes associated with the two different methods to determine if one technology/technique offers superior results compared to the other.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the difference in patients' post-operative pain level between the SAL side and the VAL side
Time Frame: 6 months
6 months
To assess the difference in patients' post-operative sensation level between the SAL side and the VAL side
Time Frame: 6 months
6 months
To assess the difference in post-operative patient preference between the SAL side and the VAL side
Time Frame: 6 months
6 months
To assess the difference in post-operative ecchymosis between the SAL side and the VAL side
Time Frame: 6 months
6 months
To assess the difference in post-operative skin retraction between the SAL side and the VAL side
Time Frame: 6 months
6 months
To assess the difference in the amount of aspirate blood content between the SAL side and the VAL side
Time Frame: 1 day
1 day
To assess any difference in the amount or degree of complications using the the SAL procedure versus the VAL procedure
Time Frame: 6 months
6 months
To assess the difference in the time required for the SAL procedure versus the time required for the VAL procedure.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sound Surgical Technologies, LLC.

Investigators

  • Principal Investigator: Onelio Garcia, MD, F.A.C.S, Plastic Surgery Center of South Florida
  • Principal Investigator: Michael Nagy, MD, F.A.C.S, Personal Enhancement Center
  • Principal Investigator: Paul F Vanek, MD, F.A.C.S., Lake Hospital Systems

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

August 4, 2008

First Submitted That Met QC Criteria

August 8, 2008

First Posted (ESTIMATE)

August 11, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SST40.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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