Non-invasive Cooling of Subcutaneous Fat

A Prospective, Multi-Center Clinical Study of Non-Invasive Cooling of Subcutaneous Fat

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: Fat Disorder
• Intervention / Treatment: Device: Zeltiq Dermal Cooling Device

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Dublin, California, United States
      • Investigational Site
    • Fremont, California, United States
      • Investigational Site
    • Pleasanton, California, United States
      • Investigational Site
    • San Ramon, California, 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 the flanks, thighs, abdomen, or back.
3. Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month.
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 is taking 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: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group 1; Cooling Intensity Factor = 33 Duration = 60 minutes	Device: Zeltiq Dermal Cooling Device; Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
Experimental: Treatment Group 2; Cooling Intensity Factor = 37 Duration = 30 minutes	Device: Zeltiq Dermal Cooling Device; Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
Experimental: Treatment Group 3; Cooling Intensity Factor = 37 Duration = 45 minutes	Device: Zeltiq Dermal Cooling Device; Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
Experimental: Treatment Group 4; Cooling Intensity Factor = 42 Cooling Duration = 30 minutes	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	Measure Description	Time Frame
Change in Fat Layer Thickness of the Treated Flank	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.	Baseline and 6 months
Percentage of Subjects Expressing Satisfaction With the Procedure	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.	6 months post-treatment follow-up visit
Percentage of Correctly Identified Pre-treatment Photographs	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.	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Zeltiq Aesthetics
• Investigators: Study Chair: Kerrie Jiang, Zeltiq Aesthetics

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: May 13, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: JM07001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes