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

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

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.

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.

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