Bilateral; Flank Study With Crown Cooling Insert

Not Applicable

Completed

Conditions: Body Fat Disorder

Interventions: Device: The ZELTIQ CoolSculpting System

Registration Number: NCT02554760

Lead Sponsor: Zeltiq Aesthetics

Brief Summary: Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flank using an applicator with and without the Crown Cooling Insert.

Detailed Description: This study will evaluate the Zeltiq CoolSculpting System when used with the standard CoolCore applicator and the CoolCore Applicator and the Crown Cooling Insert accessory.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 19

Inclusion Criteria

Male or female subjects > 22 years of age and < 65 years of age.
Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
No weight change exceeding 5% of body weight 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 maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the course of the study.
Subject has read and signed the study written informed consent form.

Exclusion Criteria

Subject has had a surgical procedure(s) in the area of intended treatment.
Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 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 known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
Subject is taking or has taken diet pills or supplements within the past month.
Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
Subject is pregnant or intending to become pregnant during the study period (in the next 5 months).
Subject is lactating or has been lactating in the past 6 months.
Subject has a history of hernia in the areas to be treated.
Subject is unable or unwilling to comply with the study requirements.
Subject is currently enrolled in a clinical study of any other 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.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Study Participants	The ZELTIQ CoolSculpting System	This is a split body study in which all subjects will receive bilateral flank treatment with CoolSculpting. The investigator will determine one flank for treatment using the CoolCore applicator without an accessory for a duration of 60 minutes at a protocol-defined temperature. The contralateral flank will be treated with the standard CoolCore Applicator using an applicator accessory, the Crown Cooling Insert (CCI) at a protocol-defined temperature for a duration of up to 45 minutes. All enrolled subjects receive identical treatments; the investigator will use alternate subject numbers to balance which flank to treat with and without the CoolCore applicator accessory, such that all even subject numbers will receive treatment using the Standard CoolCore on the right flank and odd subject numbers will receive the same treatment on the left flank.

Primary Outcome Measures

Name	Time	Method
Percentage of Correctly Identified Pre-treatment Photos by a Panel of Blinded Independent Reviewers	12 weeks post-treatment	Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Success will be defined as at least 70% correct identification of the pre-treatment images for flanks treated with each treatment parameter by at least 2 of 3 reviewers.
Safety of the Zeltiq CoolSculpting System Using the CoolCore Applicator With and Without the Crown Cooling Insert	Enrollment through the 12 week post-treatment follow-up visit	The safety endpoint is the number of unanticipated adverse device effects (UADE) as well as the number of device and/or procedure-related adverse events. Adverse events are collected from the time of enrollment through the 12 week final follow-up visit.

Secondary Outcome Measures

Name	Time	Method
Subject Satisfaction	12 weeks post-treatment	Subject satisfaction as assessed by questionnaire administered at 12 weeks post-treatment. The questionnaire will consist of a 5-point Likert scale with the following selections options: 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither satisfied nor unsatisfied; 4) somewhat satisfied; 5) very satisfied. jIn addition, free-text fields provided options for subjects responses.