CoolSculpting and RF for the Submental

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of sequential use of CoolSculpting (Cryolipolysis) and radiofrequency treatment of the submental and submandibular area.

Official Title
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A Feasibility Study to Explore the Safety and Efficacy of Cryolipolysis Followed by Radiofrequency Treatment for Submental and Submandibular Contouring

Conditions
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Body Fat Disorder

Intervention / Treatment
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* Device: The ZELTIQ System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male or female subjects ≥22 years of age and ≤65 years of age. Treatment area skin fold thickness > 1cm (measured by caliper). Dissatisfaction with the treatment area expressed by the subject as a rating of 0, 1 or 2 using the Subject Self Rating Scale (SSRS) as determined at Screening visit. No weight change exceeding 5% of body weight in the preceding month. Agreement to maintain his/her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study. Subject has signed a written informed consent form Exclusion Criteria Body Mass Index ≥ 46.2 as determined at screening. Excessive skin laxity in the treatment area for which reduction of subcutaneous fat may, in the opinion of the investigator, result in an unacceptable aesthetic result. Prominent platysmal bands at rest which may interfere with assessment of treatment area. Evidence of any cause of enlargement in the treatment area other than localized subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands. Significant enlargement on the anterior neck that may prevent the proper placement of the applicator e.g. enlarged thyroid glands. Treatment with dermal fillers, chemical peels, radiofrequency or laser procedures that may affect contour in the treatment area within the past 6 months. Botulinum toxin, deoxycholic acid, or other aesthetic drug injections within the treatment area in the past 6 months. History of facial nerve paresis or paralysis (such as Bell's palsy). History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) or implant in or adjacent to the area of intended treatment. History of prior neck surgery, or prior surgery in the area of intended treatment. Current infection in and adjacent to treatment area. Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria. Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. Currently taking or has taken diet pills or weight control supplements within the past month. Any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation. Active implanted device such as a pacemaker, automatic implantable cardioverter/defibrillator (AICD), drug delivery system, or any other implantable electrical device. Pregnant or intending to become pregnant in the next 6 months. Lactating or has been lactating in the past 6 months. Unable or unwilling to comply with the study requirements including remaining clean shaven for all study visits. Currently enrolled in a clinical study of an unapproved investigational drug or device. 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: 22 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: Fat Reduction<br>The treatments are designed to see if the fat can be reduced in the submental/submandibular area. | Device: The ZELTIQ System<br>* The CoolSculpting machine will be used to perform the treatments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of unanticipated adverse device effects (UADE). It is expected there will be zero UADE's. | The primary safety endpoint is measurement of unanticipated adverse device effects. All adverse events reported during and following the treatment will be included in the safety analysis. The frequency and proportion of subjects reporting each type of adverse event will be tabulated by relationship with the treatment and severity of the event. | 12-weeks post final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of overall treatment outcome in submental and submandibular area using Subject-graded GAIS (SGAIS) | Overall improvement in the targeted area will be assessed by the subject using the GAIS at 12-weeks post-final treatment. The assessment will consist of writing the outcome as: Very much improved; much improved; improved; no change; worse; much worse; very much worse. | 12-weeks post final treatment |