VASER-Assisted Lipoplasty Compared With Suction-Assisted Lipoplasty

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: Suction-assisted Lipoplasty
* Device: VASER-assisted lipoplasty


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SAL<br>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<br>* 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<br>* Other names: Suction-assisted lipoplasty, Liposuction;|
| Active Comparator: VAL<br>Each patient will have VASER- assisted lipoplasty on the opposite side of the body. This will be the comparison side. | Device: VASER-assisted lipoplasty<br>* 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<br>* Other names: VAL, VASER, LipoSelection, 3rd Generation UAL;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lipoplasty, liposuction, VASER, body contouring, body sculpting, Any patient, expressing, interest, in elective surgery