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

Solta Medical4 sites in 2 countries60 target enrollmentJuly 2012

ConditionsTreatment of Adipose Tissue in the Thighs

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Treatment of Adipose Tissue in the Thighs
Sponsor: Solta Medical
Enrollment: 60
Locations: 4
Primary Endpoint: Clinical Improvement in Thigh Circumference
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

January 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Solta Medical

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Clinical Improvement in Thigh Circumference

Time Frame: 12 weeks (minus baseline)

Clinical improvement measured by change from baseline thigh circumference after treatment

Secondary Outcomes

Safety Assessment(1, 4, 8, 12 weeks)
Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator(12 weeks)
Patient Satisfaction Using 1-5 Likert Scale(12 weeks)
Subcutaneous Adipose Thickness(12 weeks)
Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement(12 weeks)