Completed

NCT Number: NCT01823653

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

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.

Completed

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Key information

Conditions

Treatment of Adipose Tissue in the Thighs

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Solish M.D., Toronto, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposonix System (Model 2)

Device

Treatment of Subcutaneous Adipose Tissue in the thighs using High Intensity Focused Ultrasound

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

Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator

Time frame: 12 weeks

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
Patient Satisfaction Using 1-5 Likert Scale

Time frame: 12 weeks

Likert scale ranges from 1=Very Dissatisfied to 4=satisfied, 5=very satisfied. Percentage of participants rated 4 and 5 are reported below
Safety Assessment

Time frame: 1, 4, 8, 12 weeks

Discomfort level during treatment using the Visual Analog Scale (VAS) and post-treatment skin reponses or side effects using a 0-3 severity scale.
Subcutaneous Adipose Thickness

Time frame: 12 weeks

Ultrasound assisted measurement of adipose tissue thickness
Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement

Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Solta Medical

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Apr 4, 2013
Registry last updated: Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.