UltraShape Power in Combination With U-sculpt-n Transducer

Study Overview
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Brief Summary
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Prospective, open label, self - controlled, single arm, clinical study to assess the performance of the UltraShape Power using the U-Sculpt-N on outer thigh and/or flank for circumference reduction versus self-control.

Official Title
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Clinical Evaluation of UltraShape Power System in Conjunction With the U-Sculpt-N Transducer for Non-invasive Circumference Reduction

Conditions
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Circumference Reduction

Intervention / Treatment
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* Device: UltraShape Power


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject ≥18 and ≤60 years of age at the time of enrollment Fat thickness of at least 1.5 cm in the outer thigh and/or flank (measured by calibrated caliper) For women of child-bearing potential: negative urine pregnancy test General good health confirmed by medical history and skin examination of the treated area Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed. Exclusion Criteria: History of un-balanced hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease Having a permanent implant in the treated area, such as metal plates, or an injected chemical substance such as silicone Previous liposuction in the treatment areas within 12 months History of skin disease in the treatment area, known tendency to form keloids or poor wound healing Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months Childbirth within the last 12 months or women who are breastfeeding a child

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: prospective, single arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br> | Device: UltraShape Power<br>* non-invasive body contouring procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outer thigh circumference reduction | To evaluate circumference reduction of outer thigh post treatment with UltraShape Power device used with the U-Sculpt-N transducer versus control side. | up to 24 week | 
| Treatment-related adverse events | The frequency and severity of all treatment-related adverse events during and after using the UltraShape Power device used with the U-Sculpt-N transducer. | up to 24 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject satisfaction questionnaire | The assessment of subject satisfaction with treatment will be recorded during relevant visits (starting following the first treatment) using a 5-point Likert scale | up to 24 week |