VASER-Assisted Lipoplasty Compared With Suction-Assisted Lipoplasty

Sound Surgical Technologies, LLC.21 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

Suction-assisted LipoplastyDEVICE

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

VASER-assisted lipoplastyDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Plastic Surgery Center of South Florida

Miami, Florida, United States

Personal Enhancement Center

Toms River, New Jersey, United States

Paul F. Vanek, M.D., F.A.C.S.

Mentor, Ohio, United States

Outcomes

Primary Outcomes

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

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

Time frame: 6 months

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

Time frame: 6 months

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

Time frame: 6 months

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

Time frame: 6 months

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

Time frame: 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

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

Time frame: 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

Data from ClinicalTrials.gov

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