Thigh Circumference Reduction Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction of thigh circumference.

Detailed Description
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The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction of thigh circumference. At investigator's discretion, each subject will receive up to three treatments on one thigh and will be scheduled for two follow-up visits after the final treatment. The treated thigh will be clinically evaluated for side effects and both treated and untreated control thigh will be measured and photographed at each visit for analysis. Subjects will also be weighted at each visit and asked to fill out a survey during follow-up visits.

Official Title
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Cutera Radio Frequency Device for Thigh Circumference Reduction

Conditions
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Reduction of Localized Excess Fat

Intervention / Treatment
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* Device: Cutera Radio Frequency Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index between 20 and 35 Presence of cellulite grades II, III or IV according to GLD scale Visible bi-lateral thigh fat Thigh area to be treated to measure at least 30.0mm in vertical fold, as measured with industry standard fat caliper 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 Exclusion Criteria: Significant weight fluctuation (+/-10 lbs) in the past 6 months Taking weight-loss medications/supplements Participation in any other clinical study Cellulite treatment within 3 months of the treatment Surgical or non-surgical treatments to the target area in the last 12 months, e.g., liposuction Prior treatment to the target area within the last 12 months Arteriosclerosis or weakened blood vessels Heart disease Thromboembolic disease Diagnosed or documented immune system disorders Bleeding disorders. Presence of uncontrolled hypertension Taking prescription anticoagulants History of keloid formation 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 Infection in the target area Implanted electrical device(s) Pregnant or lactating

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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>The thigh treated with the RF device | Device: Cutera Radio Frequency Device<br>* Up to three treatments, one pass, dosage range of 15-60 kJ.<br>* Other names: Callisto, TruForm, TruSculpt;|
| No Intervention: Untreated Thigh<br>The untreated thigh | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms | Mean difference of change from baseline between two arms: [Treated arm - Untreated arm] | Baseline and 6 months post final treatment | 
| Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms | Mean difference of change from baseline between two arms: [Treated arm - Untreated arm] | Baseline and 6 months post final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Satisfaction |  | Baseline and 6 months post final treatment | 
| Adverse Events |  | At each visit (treatment and follow-up) or until resolution of AEs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cellulite, Adipose tissue, Circumference, Reduction, Thigh