N/A
Completed N=60
Treatment of Subcutaneous Adipose Tissue in the Thighs Using High Intensity Focused Ultrasound
Treatment of Adipose Tissue in the Thighs
Source: ClinicalTrials.gov NCT01823653 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcomePrimary: Clinical Improvement in Thigh Circumference — -1.22; -0.59 centimeter
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Improvement in Thigh Circumference |
-1.22; -0.59 | — |
| SECONDARY Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator |
79.3 | — |
| SECONDARY Patient Satisfaction Using 1-5 Likert Scale |
56.9 | — |
| SECONDARY Safety Assessment |
— | — |
| SECONDARY Subcutaneous Adipose Thickness |
— | — |
| SECONDARY Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement |
3.8 | — |
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
Data sourced from ClinicalTrials.gov (NCT01823653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.