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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study to Investigate the Safety and Efficacy of Treatment of Subcutaneous Adipose Tissue in the Thighs Using the Liposonix System (Model 2)

Conditions
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Treatment of Adipose Tissue in the Thighs

Intervention / Treatment
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* Device: Liposonix System (Model 2)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated Thigh<br>Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2) | Device: Liposonix System (Model 2)<br>* Treatment of Subcutaneous Adipose Tissue in the thighs using High Intensity Focused Ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Improvement in Thigh Circumference | Clinical improvement measured by change from baseline thigh circumference after treatment | 12 weeks (minus baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator | 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 | 12 weeks | 
| Patient Satisfaction Using 1-5 Likert Scale | Likert scale ranges from 1=Very Dissatisfied to 4=satisfied, 5=very satisfied. Percentage of participants rated 4 and 5 are reported below | 12 weeks | 
| Safety Assessment | Discomfort level during treatment using the Visual Analog Scale (VAS) and post-treatment skin reponses or side effects using a 0-3 severity scale. | 1, 4, 8, 12 weeks | 
| Subcutaneous Adipose Thickness | Ultrasound assisted measurement of adipose tissue thickness | 12 weeks | 
| Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement | 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 | 12 weeks |