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

This study has been completed.
Sponsor:
Information provided by:
Sound Surgical Technologies, LLC.
ClinicalTrials.gov Identifier:
NCT00731354
First received: August 4, 2008
Last updated: June 6, 2011
Last verified: June 2011
History of Changes

August 4, 2008
June 6, 2011
July 2007
September 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00731354 on ClinicalTrials.gov Archive Site
  • To assess the difference in patients' post-operative pain level between the SAL side and the VAL side [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the difference in patients' post-operative sensation level between the SAL side and the VAL side [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the difference in post-operative patient preference between the SAL side and the VAL side [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the difference in post-operative ecchymosis between the SAL side and the VAL side [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the difference in post-operative skin retraction between the SAL side and the VAL side [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the difference in the amount of aspirate blood content between the SAL side and the VAL side [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • To assess any difference in the amount or degree of complications using the the SAL procedure versus the VAL procedure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the difference in the time required for the SAL procedure versus the time required for the VAL procedure. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
VASER-Assisted Lipoplasty Compared With Suction-Assisted Lipoplasty
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Healthy
  • 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 Name: Suction-assisted lipoplasty, Liposuction
  • 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 Name: VAL, VASER, LipoSelection, 3rd Generation UAL
  • Active Comparator: SAL
    Each patient will have Suction Assisted Lipoplasty procedure on one side of the body (this will be considered the control side)
    Intervention: Device: Suction-assisted Lipoplasty
  • Active Comparator: VAL
    Each patient will have VASER- assisted lipoplasty on the opposite side of the body. This will be the comparison side.
    Intervention: Device: VASER-assisted lipoplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
April 2009
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00731354
SST40.2
No
Amber Eruchalu, M.S., CCRP./ Clinical Program Manager, Sound Surgical Technologies, LLC
Sound Surgical Technologies, LLC.
Not Provided
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
Sound Surgical Technologies, LLC.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP