Treatment of Subcutaneous Adipose Tissue in the Thighs Using High Intensity Focused Ultrasound

Not Applicable

Completed

Brief Summary: The purpose of this study is to assess the safety and efficacy of treatment with the Liposonix System (Model 2) for the circumferential reduction of subcutaneous adipose tissue (SAT) of the thighs.

Detailed Description: Subjects received a single treatment (Liposonix System) on one randomly assigned thigh. The opposite thigh was not treated and served as a control for each subject.

Recruitment & Eligibility

Inclusion Criteria

Male or female subjects between 18-60 years of age
Body Mass Index of ≤30 lb/in2
Thickness of adipose tissue is at least 1.0 cm beyond the selected focal depth in the area to be treated (≥2.3cm)
Subjects must agree not to alter their regular diet or exercise routines during the course of the study
Subjects must be willing and able to comply with all study visit requirements, procedures, and assessments
Subject must understand the nature of the study and sign an IRB approved Informed Consent

Exclusion Criteria

Subjects is pregnant
Subjects diagnosed with a coagulation disorder or receiving anticoagulant therapy
Subject has had prior aesthetic procedures in the area to be treated
Subjects has pacemaker, defibrillator, or other implantable electrical device
Subject has significant circumferential asymmetry between thighs

Arm && Interventions

Group	Intervention	Description
Treated Thigh	Liposonix System (Model 2)	Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2)

Primary Outcome Measures

Name	Time	Method
Clinical Improvement in Thigh Circumference	12 weeks (minus baseline)	Clinical improvement measured by change from baseline thigh circumference after treatment

Secondary Outcome Measures

Name	Time	Method
Safety Assessment	1, 4, 8, 12 weeks	Discomfort level during treatment using the Visual Analog Scale (VAS) and post-treatment skin reponses or side effects using a 0-3 severity scale.
Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator	12 weeks	Investigator improvement at 12 weeks using the GAIS Scale, as presented based on percentage of subjects showing improvement. Outcome presented in % of participants that had GAIS scores of either 4 (improved) or 5 (much improved) at 12 weeks post treatment. \*GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved
Patient Satisfaction Using 1-5 Likert Scale	12 weeks	Likert scale ranges from 1=Very Dissatisfied to 4=satisfied, 5=very satisfied. Percentage of participants rated 4 and 5 are reported below
Subcutaneous Adipose Thickness	12 weeks	Ultrasound assisted measurement of adipose tissue thickness
Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement	12 weeks	Mean Investigator improvement at 12 weeks using the GAIS Scale. \*GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved

Locations (4): Van Dyke Laser and Skin
🇺🇸
Paradise Valley, Arizona, United States
Solta Medical Aesthetic Center
🇺🇸
Hayward, California, United States
Jewell Plastic Surgery Center
🇺🇸
Eugene, Oregon, United States
Solish M.D.
🇨🇦
Toronto, Ontario, Canada