VASER-Assisted Lipoplasty Compared With Suction-Assisted Lipoplasty

Phase 4

Completed

• Conditions: Healthy
• Interventions: Device: Suction-assisted Lipoplasty; Device: VASER-assisted lipoplasty

• Registration Number: NCT00731354
• Lead Sponsor: Sound Surgical Technologies, LLC.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-08-04
• Study First Submitted QC: 2008-08-08
• Study First Posted: 2008-08-11
• Primary Completion: 2008-09
• Study Completion: 2009-04
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-06
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SAL	Suction-assisted Lipoplasty	Each patient will have Suction Assisted Lipoplasty procedure on one side of the body (this will be considered the control side)
VAL	VASER-assisted lipoplasty	Each patient will have VASER- assisted lipoplasty on the opposite side of the body. This will be the comparison side.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

Paul F. Vanek, M.D., F.A.C.S.; 🇺🇸 Mentor, Ohio, United States

Plastic Surgery Center of South Florida; 🇺🇸 Miami, Florida, United States

Personal Enhancement Center; 🇺🇸 Toms River, New Jersey, United States