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.

Study Overview

• Status: Completed
• Conditions: Treatment of Adipose Tissue in the Thighs
• Intervention / Treatment: Device: Liposonix System (Model 2)

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Solish M.D.
• United States
  • Arizona
    • Paradise Valley, Arizona, United States, 85253
      • Van Dyke Laser and Skin
  • California
    • Hayward, California, United States, 94545
      • Solta Medical Aesthetic Center
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Jewell Plastic Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Solta Medical

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: March 29, 2013
• First Submitted That Met QC Criteria: March 29, 2013
• First Posted (Estimate): April 4, 2013

Study Record Updates

• Last Update Posted (Estimate): December 31, 2014
• Last Update Submitted That Met QC Criteria: December 10, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 12-130-LP-H