Multiple CoolSculpting Treatment Study

Zeltiq Aesthetics35 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Body Fat Disorder

Interventions

The Zeltiq CoolSculpting SystemDEVICE

Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: 1. Lower Abdomen - One 60 minute cycle with CoolMax, 2. 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.

Locations (3)

Innovation Research Center

Pleasanton, California, United States

Ed Becker, MD

Walnut Creek, California, United States

Bowes Dermatology Group

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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