Non-invasive Cooling of Subcutaneous Fat

Not Applicable

Completed

Conditions: Fat Disorder

Interventions: Device: Zeltiq Dermal Cooling Device

Registration Number: NCT00762307

Lead Sponsor: Zeltiq Aesthetics

Brief Summary: The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat.

Detailed Description: The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat using the Zeltiq Dermal Cooling device.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

Inclusion Criteria

Male or female subjects > 18 years of age.
Subject has clearly visible fat on the flanks, thighs, abdomen, or back.
Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month.
Subject has read and signed a written informed consent form.

Exclusion Criteria

Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years.
Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months.
Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
Subject is taking diet pills within the past 6 months.
Subject is unable or unwilling to comply with the study requirements.
Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation.
Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
Patient is pregnant or intending to become pregnant in the next 9 months.
Patient is lactating or has been lactating in the past 9 months.
Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 1	Zeltiq Dermal Cooling Device	Cooling Intensity Factor = 33 Duration = 60 minutes
Treatment Group 3	Zeltiq Dermal Cooling Device	Cooling Intensity Factor = 37 Duration = 45 minutes
Treatment Group 4	Zeltiq Dermal Cooling Device	Cooling Intensity Factor = 42 Cooling Duration = 30 minutes
Treatment Group 2	Zeltiq Dermal Cooling Device	Cooling Intensity Factor = 37 Duration = 30 minutes

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Expressing Satisfaction With the Procedure	6 months post-treatment follow-up visit	Subject satisfaction as determined by the completion of a questionnaire at the 6 month follow-up visit, and, as requested, any other follow-up visits.
Change in Fat Layer Thickness of the Treated Flank	Baseline and 6 months	The change in fat layer thickness as demonstrated by measurement of fat layer layer thickness using ultrasound images taken in the treated area and on the contralateral flank (control) at baseline and at the 6 month follow-up. Data collected on the untreated side and the treated side will be combined to determine the normalized change in fat layer thickness for each subject. The mean percent fat layer reduction across all treatment groups will be presented, as well as for each treatment group.
Percentage of Correctly Identified Pre-treatment Photographs	Baseline and 6 months	Change in the treated vs. untreated areas will be assessed for changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the control and treated flanks. Reviewers will be practicing dermatologists. All reviewers will be blinded to post-treatment vs. baseline and/or untreated flank. 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.Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. Results reflect the percentage of correctly identified images.