Multiple CoolSculpting Treatment Study

Study Overview
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Brief Summary
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To evaluate the safety of same-day CoolSculpting treatments and to assess the impact on serum lipids and liver-related tests.

Detailed Description
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The study will evaluate the safety of multiple same-day CoolSculpting treatments and will assess any impact on serum lips or liver-related analytes,

Official Title
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Safety Evaluation of Multiple CoolSculpting Treatments

Conditions
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Body Fat Disorder

Intervention / Treatment
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* Device: The Zeltiq CoolSculpting System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male or female subjects > 18 years of age. Subject who has been assessed to receive multiple CoolSculpting treatments on the abdomen and flanks, defined as follows: Lower Abdomen - One 60 minute cycle with CoolMax, Right and Left Flank - One 60 minute cycle per flank, with CoolCurve+ or CoolCore, simultaneously. Subject has not had weight change exceeding 10 pounds in the preceding month. Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches. Subject agrees to not making any major changes in their diet or lifestyle during the course of the study. Subject has read and signed a written informed consent form. Exclusion Criteria Subject has had an invasive (e.g., liposuction, mesotherapy, abdominoplasty) or non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months. Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. Subject has a history of hernia in the area(s) to be treated. Subject is pregnant or intending to become pregnant during the study period (in the next 4 months). Subject is lactating or has been lactating during the past 3 months. Subject is unable or unwilling to comply with the study requirements, such as blood draw. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. Subject has a history of lipodosis or other confounding metabolic diseases. Subject is taking or has taken medication within the past 3 months which may affect the metabolic function. Patient has a history of diabetes. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CoolSculpting Treatment Group<br>CoolSculpting treatments will be performed on all subjects with 1 cooling cycle on the lower abdomen, plus simultaneous treatment of both flanks, one cooling cycle each. Two control units will be utilized at protocol-defined temperatures and durations. | Device: The Zeltiq CoolSculpting System<br>* Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.<br>* Other names: Lipolysis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Liver- Related Tests Over Time | Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory value over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness. | Pre-treatment; 1 week, 4 weeks, and 12 weeks post-treatment | 
| Evaluation of Liver-Related Tests Over Time | Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness. | Pretreatment, 1 week, 4 weeks 12 weeks post-treatment | 
| Evaluation of Serum Lipid Values Over Time | Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness. | Pre-treatment, 1 week, 4 weeks, 12 weeks post-treatment | 
| Safety of the Device and/or Procedure as Assessed by the Incidence of SAE and UADE | The primary safety end point is the incidence of Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE). | 12 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as Evaluated by the Number and Severity of All Reported Adverse Events. | All adverse will be assessed for frequency and severity from the time of enrollment though the 12 week follow-up visit. | 12 weeks post-treatment | 
| Pain: Assessment of Pain Scores Reported on the Day of Treatment and at 12 Weeks Post-treatment. | Pain scores are collected using a 0 (no pain) to 10 (worst possible pain) scale. Scores will be collected immediately post-treatment and at the 12 week follow-up visit. | Treatment day and 12 week post-treatment follow-up | 
| Side Effects in Treatment Area | Clinical assessments of the skin at the treatment sites to be performed immediately post-treatment, and at the 12 week follow-up visit. Subjects will be evaluated for skin changes at the treatment sites. The scale used by clinicians for the assessments is 0 = absent, 1= minor, 2= moderate, 3= severe. | Treatment day and 12 week post-treatment follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipolysis, Cryolipolysis, Fat Reduction