Status:
COMPLETED
Treatment of Subcutaneous Adipose Tissue in the Thighs Using High Intensity Focused Ultrasound
Lead Sponsor:
Solta Medical
Conditions:
Treatment of Adipose Tissue in the Thighs
Eligibility:
All Genders
18-60 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01823653
Start Date
July 1 2012
End Date
January 1 2013
Last Update
December 31 2014
Active Locations (4)
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1
Van Dyke Laser and Skin
Paradise Valley, Arizona, United States, 85253
2
Solta Medical Aesthetic Center
Hayward, California, United States, 94545
3
Jewell Plastic Surgery Center
Eugene, Oregon, United States, 97401
4
Solish M.D.
Toronto, Ontario, Canada