The Trusculpt (Radio Frequency) Device For Thigh Circumference Reduction

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio Frequency) device in the reduction of thigh circumference.

Detailed Description
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The primary efficacy variable for this study is the comparison of mean change in thigh circumference from baseline to 12 weeks between two arms. The primary research hypothesis is that the mean change in thigh circumference is ≥ 1 cm (indicating mean reduction).

Official Title
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The Cutera Trusculpt Device For Thigh Circumference Reduction

Conditions
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Body Fat

Intervention / Treatment
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* Device: Trusculpt (Radio Frequency) Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Minimum age of 18 years Non-smoking for at least 3 months and willing to refrain from smoking for the duration of the study. Post-menopausal, or on birth control and/or no plans to become pregnant for the duration of the study. Body Mass Index (BMI) ≤ 30 Visible fat in the thigh / saddlebag area to be treated Subject must be able to read, understand and sign the Consent Form Subject must adhere to the follow-up schedule and study instructions Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study (within 6 lbs of the weight measure at the baseline assessment) Exclusion Criteria: Taking weight-loss medications/supplements Simultaneous participation in any other clinical study Prior surgical treatment to the target area, e.g., liposuction or abdominoplasty Prior treatment to the target area within the last 12 months e.g., radio frequency or cryolysis Arteriosclerosis or weakened blood vessels Heart disease Thromboembolic disease Diagnosed or documented immune system disorders (including Panniculitis) Bleeding disorders Presence of uncontrolled hypertension Taking prescription anticoagulants History of keloid formation History of malignant tumors in the target area Diabetes Any disease or condition that could impair wound healing Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles Infection in the target area Implanted electrical device(s) or metallic implants Pregnant or lactating

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated Thigh<br>Trusculpt (Radio Frequency) Device | Device: Trusculpt (Radio Frequency) Device<br> <br> |
| No Intervention: Untreated Contra-lateral Thigh<br>To be used as the self control in this split body study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Thigh Circumference From Baseline | Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment. | Comparison of Baseline to 12 weeks post- final treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radio frequency, thigh, circumference, reduction