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

Solta Medical

Status

Completed

Conditions

Treatment of Adipose Tissue in the Thighs

Treatments

Device: Liposonix System (Model 2)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01823653

12-130-LP-H

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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