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Completed

NCT Number: NCT00731354

VASER-Assisted Lipoplasty Compared With 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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Plastic Surgery Center of South Florida, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suction-assisted Lipoplasty

Device

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

VASER-assisted lipoplasty

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. To assess the difference in patients' post-operative pain level between the SAL side and the VAL side

    Time frame: 6 months

  2. To assess the difference in patients' post-operative sensation level between the SAL side and the VAL side

    Time frame: 6 months

  3. To assess the difference in post-operative patient preference between the SAL side and the VAL side

    Time frame: 6 months

  4. To assess the difference in post-operative ecchymosis between the SAL side and the VAL side

    Time frame: 6 months

  5. To assess the difference in post-operative skin retraction between the SAL side and the VAL side

    Time frame: 6 months

  6. To assess the difference in the amount of aspirate blood content between the SAL side and the VAL side

    Time frame: 1 day

  7. To assess any difference in the amount or degree of complications using the the SAL procedure versus the VAL procedure

    Time frame: 6 months

  8. To assess the difference in the time required for the SAL procedure versus the time required for the VAL procedure.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Sound Surgical Technologies, LLC.

Industry

Registry information

Official study title

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

Acronym: Contra-Lateral

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Aug 11, 2008
Registry last updated
Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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