Effectiveness Study of the UltraShape® Contour I-Y for Non-Invasive Reduction in Abdominal Circumference

Study Overview
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Brief Summary
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The UltraShape® Contour I- Y system uses focused ultrasound to produce localized mechanical motion within fat tissues and cells for the purpose of producing mechanical cellular membrane disruption. It is intended for reduction in body circumference. The primary objective of this study is to evaluate the efficacy of the Contour I - Y System on abdominal circumference reduction relative to baseline pretreatment values using different treatment methods. The primary efficacy endpoint in this trial is Statistical Difference of Circumference reduction between Baseline measurement and at follow-up measurement.

Official Title
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A Baseline Controlled Study to Evaluate the Effectiveness of the UltraShape® Contour I - Y System for Non-Invasive Reduction in Abdominal Circumference

Conditions
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Reduction in Abdominal Circumference

Intervention / Treatment
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* Device: Treatment with Contour I-Y system
* Device: Treatment with Contour I-Y system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male subjects, 18-65 years of age at the time of enrollment Abdominal and flank fat thickness of at least 1.5 cm prior to initial treatment (measurement by caliper) For women of child-bearing potential: negative pregnancy test in the 24 hour period prior to enrollment (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 abdomen or love handle 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A - will undergo 3 successive treatments, 1 week apart<br>The Contour I - Y System is a non-invasive focused ultrasound, for body contouring purposes, designed to selectively disrupt sub-dermal fat cells at a designated focus 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. | Device: Treatment with Contour I-Y system<br>* The Contour I - Y System is a non-invasive focused ultrasound, for body contouring purposes, designed to selectively disrupt sub-dermal fat cells at a designated focus 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.<br>* Other names: UltraShape® Contour I - Y System;|
| Experimental: Group B - will undergo 3 successive treatments, 2 weeks apart<br>The Contour I - Y System is a non-invasive focused ultrasound, for body contouring purposes, designed to selectively disrupt sub-dermal fat cells at a designated focus 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. | Device: Treatment with Contour I-Y system<br>* The Contour I - Y System is a non-invasive focused ultrasound, for body contouring purposes, designed to selectively disrupt sub-dermal fat cells at a designated focus 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.<br>* Other names: UltraShape® Contour I - Y System;Device: Treatment with Contour I-Y system<br>* The Contour I - Y System is a non-invasive focused ultrasound, for body contouring purposes, designed to selectively disrupt sub-dermal fat cells at a designated focus 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.<br>* Other names: UltraShape® Contour I - Y System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to evaluate the efficacy of the Contour I - Y System on abdominal circumference reduction relative to baseline pretreatment values using different treatment methods. |  | 3.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective of this study subject satisfaction measured with a self-assessment questionnaire |  | 3.5 months | 
| Rate of device and procedure related adverse event adverse |  | 3.5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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body circumference, Non-Invasive Reduction