Radio Frequency (RF) Device for Reduction in Size of Localized Areas of the Body

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 in size of localized areas of the body.

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 in size of localized areas of the body, including, but not limited to, areas on the abdomen, leg, and arm. At investigator's discretion, each subject will receive up to three treatments and will be scheduled for two follow-up visits after the final treatment. The treated area will be measured and photographed ar 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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Pilot Study to Evaluate the Cutera RF Device for Reduction in Size of Localized Areas of the Body, Including, But Not Limited to, Areas on the Abdomen, Leg, and Arm

Conditions
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Cellulite

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: Female or Male 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 with no plans to become pregnant for the duration of the study (female only) Minimum Body Mass Index of 20 Visible fat in the area to be treated Area to be treated to measure at least 20.0mm 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, and agree to maintain the same weight throughout the study (within 6 lbs of initial weight) 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, large moles 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: 55 Years

Sexes Eligible for Study
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All

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RF treatment<br>Abdomen, flank or thigh treated with 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;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Circumference (cm) |  | 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 | 
| The Number of Participants With Adverse Events | At each visit (treatment and follow-up) or until resolution of AEs | Up to 6 months after the last treatment | 

 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, Abdomen, Flank