Evaluation of the Treatment of Adipose Tissue With Liposonix System (Model 2) Using a New Treatment Method

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, efficacy, and tolerability of treatment with the Liposonix System (Model 2)using a single pass technique.

Official Title
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An Evaluation of the Safety and Effectiveness of Treatment of Adipose Tissue With the Liposonix System (Model 2) Using a New Treatment Method

Conditions
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Subcutaneous Adipose Tissue

Intervention / Treatment
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* Device: Liposonix System (Model 2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18 to 65 years of age Body Mass Index of ≤30 kg/m2 Thickness of subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.3 cm Subjects must agree to not alter their normal and regular diet or exercise routines during the course of the study Subject must understand the nature of the study and sign an IRB approved Informed Consent Exclusion Criteria: Subject is pregnant Subject is diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation Subject has diabetes or cardiovascular disease Subject has had prior aesthetic procedures to the region to be treated Subject has had previous open or laparoscopic surgery in the anticipated treatment area Subject is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures Subjects undergoing chronic steroid or immunosuppressive therapy Subject has cardiac pacemakers or any implantable electrical device Subject has a History of cancer Subject has sensory loss or dysesthesia in the area to be treated Subjects who are unable, or lack the capacity, to self consent

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment at level 1<br>Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2) | Device: Liposonix System (Model 2)<br> <br> |
| Experimental: Treatment at level 2<br>Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2) | Device: Liposonix System (Model 2)<br> <br> |
| Experimental: Treatment at level 3<br>Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2) | Device: Liposonix System (Model 2)<br> <br> |
| Active Comparator: Treatment with 3 passes at 60 J/cm2<br>Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence) | Device: Liposonix System (Model 2)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline | Change from baseline in waist circumference 12 weeks after treatment was assessed by blinded evaluators. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline | Change from baseline in waist circumference 4, 8, and 16 weeks after treatment was assessed by blinded evaluators. | 4 weeks, 8 weeks, 16 weeks | 
| Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | GAIS evaluations were performed by Investigators at the 4, 8, 12, and 16 week visits. Investigators used direct visual assessment (live assessment) compared to photographs of subjects taken before treatment (baseline) to assess improvement in the treatment area. Scoring was based upon a five point grading System: 5 - Much Improved, 4 - Improved, 3 - No Change, 2 - Worse, or 1 - Much Worse. The definition of an improvement of the GAIS score included either a GAIS score of 'Improved' or 'Much Improved'. | 4, 8, 12, and 16 weeks | 
| Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) | Subjects self-assessed improvement in the treatment area and assigned a GAIS score at each visit. Scoring was based upon a five point grading System: 5 - Much Improved, 4 - Improved, 3 - No Change, 2 - Worse, or 1 - Much Worse. The definition of an improvement of the GAIS score included either a GAIS score of 'Improved' or 'Much Improved'. | 4, 8, 12, and 16 weeks | 
| Subject Satisfaction With Treatment | Subjects rated their satisfaction with treatment results using a 5-point Likert Satisfaction Scale (5: very satisfied; 4: satisfied; 3: neither satisfied nor dissatisfied; 2: dissatisfied; 1: very dissatisfied). The subject satisfaction score was analyzed as the proportion of subjects showing improvement as defined as a score of 4 or greater ('satisfied' or 'very satisfied'). | 4, 8, 12, and 16 weeks |