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

NCT ID: NCT01823653

Last Updated: 2014-12-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Treatment of Adipose Tissue in the Thighs

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treated Thigh

Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2)

Group Type EXPERIMENTAL

Liposonix System (Model 2)

Intervention Type DEVICE

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

Interventions

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Liposonix System (Model 2)

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Solta Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Van Dyke Laser and Skin

Paradise Valley, Arizona, United States

Site Status

Solta Medical Aesthetic Center

Hayward, California, United States

Site Status

Jewell Plastic Surgery Center

Eugene, Oregon, United States

Site Status

Solish M.D.

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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12-130-LP-H

Identifier Type: -

Identifier Source: org_study_id