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
  Purpose

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.


Condition Intervention Phase
Healthy
Device: Suction-assisted Lipoplasty
Device: VASER-assisted lipoplasty
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: A Multi-Center, Prospective, Randomized, Single-Blind, Controlled Clinical Trial Comparing VASER-Assisted Lipoplasty and Suction-Assisted Lipoplasty.

Further study details as provided by Sound Surgical Technologies, LLC.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 21
Study Start Date: July 2007
Study Completion Date: April 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: VAL, VASER, LipoSelection, 3rd Generation UAL

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731354

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

Additional Information:
No publications provided

Responsible Party: Amber Eruchalu, M.S., CCRP./ Clinical Program Manager, Sound Surgical Technologies, LLC
ClinicalTrials.gov Identifier: NCT00731354     History of Changes
Other Study ID Numbers: SST40.2
Study First Received: August 4, 2008
Last Updated: June 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Sound Surgical Technologies, LLC.:
lipoplasty
liposuction
VASER
body contouring
body sculpting
Any patient
expressing
interest
in elective surgery

ClinicalTrials.gov processed this record on April 15, 2014