Ultrashape System in Combination With VelaShape II Device for Circumferential Reduction

Study Overview
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Brief Summary
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The purpose of this study is to compare the clinical performance of the Ultrashape system with VelaShape II device for reduction of the waist.

Detailed Description
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UltraShape® Contour I V3 system is a non-invasive (not breaking the skin) focused ultrasound for body contouring purposesdesigned to selectively disrupt sub-dermal fat cells employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves, remain intact. There are no thermal effects. Fat-cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time. VelaShape is a non-invasive device for Body Reshaping and Cellulite Treatment. VelaShape combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation.

Official Title
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Baseline Controlled Two-arm Multi-Center Study to Evaluate the Safety and Efficacy of Combined Multi-Focus Treatments of UltraShape® Contour I V3 System and VelaShape II Device for Non-Invasive Circumference Reduction

Conditions
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Abdominal Fat

Intervention / Treatment
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* Device: Ultrashape
* Device: Velashape II


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fat thickness of at least 1.5 cm in the anterior abdominal and flanks prior to initial treatment (measurement by caliper) For women of child-bearing potential: negative pregnancy test in the 24 hour period prior to enrollment and 24 hour period prior to each treatment or FU visit (measured in urine) General good health confirmed by medical history and skin examination of the treated area Written informed consent to participate in the study Ability to comply with the requirements of the study BMI≤ 30 Exclusion Criteria: History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy Previous liposuction in the treatment areas History of skin disease in the treatment area, known tendency to form keloids or poor wound healing Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment area Poor skin quality (i.e., laxity) Abdominal wall diastasis or hernia on physical examination Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months Obesity (BMI > 30) Childbirth within the last 12 months or women who suckling a child Any acute or chronic condition which, in the opinion of the Investigator, could interfere with the conduct of the study Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months) Inability to comply with circumference measurement procedure (e.g., inability to held breath for the required duration) Participation in another clinical study Previous body contouring treatments in the treatment areas

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Velashape II device<br>Controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation. | Device: Velashape II<br>* All subjects receive 3 successive Velashape treatments every two weeks in the anterior abdomen.<br>* Other names: Vela, Velashape;|
| Active Comparator: Ultrashape<br>The UltraShape Contour I V3 uses focused ultrasound to produce localized mechanical motion within fat tissues and cells for the purpose of producing mechanical cellular membrane disruption. | Device: Ultrashape<br>* All subjects receive 3 successive Ultrashape treatments every two weeks in the anterior abdomen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in circumference reduction between baseline and follow-up visits | The primary efficacy endpoint in this trial is the statistical difference in circumference reduction between Control (baseline measurement, Vist 2 / Day 0) and two points of follow-up measurement: 2 weeks (Visit 5 / Day 42) and 12 weeks (Visit 8 / Day 112) following the last Tx session. The following procedure will be used to compute the Circumference Difference primary endpoint: | Base line, 2 and 12 weeks post last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Safety will be evaluated based on the incidence and severity of adverse events caused by the treatments | The duration of the study, an expected average of 5 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Syneron, Velashape, ELOS, Ultrashape