Non-Invasive Cooling of Fat Cells

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.

Study Overview

• Status: Completed
• Conditions: Reduction of Unwanted Fat
• Intervention / Treatment: Device: Zeltiq Dermal Cooling Device

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States
      • Investigational Site
    • San Diego, California, United States
      • Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States
      • Investigational Site
  • Florida
    • Miami, Florida, United States
      • Investigational Site
  • Illinois
    • Chicago, Illinois, United States
      • Investigational Site
  • Maryland
    • Baltimore, Maryland, United States
      • Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States
      • Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States
      • Investigational Site
  • New Jersey
    • Hackensack, New Jersey, United States
      • Investigational Site
  • New York
    • New York, New York, United States
      • Investigational Site
  • Texas
    • Dallas, Texas, United States
      • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female subjects > 18 years of age.
2. Subject has clearly visible fat on an area of the body appropriate for treatment with the non-invasive Zeltiq cooling device such as the flanks, thighs, abdomen or back.
3. Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month and plans to maintain their weight to within ±10 pounds over the next 6 months.
4. Subject has read and signed a written informed consent form.

Exclusion Criteria:

1. Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years.
2. Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months.
3. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
4. Subject has used diet pills within the past 6 months.
5. Subject is unable or unwilling to comply with the study requirements.
6. Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation.
7. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
8. Patient is pregnant or intending to become pregnant in the next 9 months.
9. Patient is lactating or has been lactating in the past 9 months.
10. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	Device: Zeltiq Dermal Cooling Device; Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visible improvement in treated area	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Subject satisfaction	4 months

Collaborators and Investigators

• Sponsor: Zeltiq Aesthetics

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: September 27, 2008
• First Submitted That Met QC Criteria: September 29, 2008
• First Posted (ESTIMATE): September 30, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 20, 2011
• Last Update Submitted That Met QC Criteria: June 16, 2011
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: ZA07005