Non-Invasive Cooling of Fat Cells
This study has been completed.
Sponsor:
Zeltiq Aesthetics
Information provided by:
Zeltiq Aesthetics
ClinicalTrials.gov Identifier:
NCT00762437
First received: September 27, 2008
Last updated: June 16, 2011
Last verified: May 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Reduction of Unwanted Fat |
Device: Zeltiq Dermal Cooling Device |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Further study details as provided by Zeltiq Aesthetics:
Primary Outcome Measures:
- Visible improvement in treated area [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Subject satisfaction [ Time Frame: 4 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 240 |
| Study Start Date: | January 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Device: Zeltiq Dermal Cooling Device
Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male or female subjects > 18 years of age.
- 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.
- 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.
- 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 has used 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00762437
Locations
| United States, California | |
| Investigational Site | |
| Sacramento, California, United States | |
| Investigational Site | |
| San Diego, California, United States | |
| United States, District of Columbia | |
| Investigational Site | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| Investigational Site | |
| Miami, Florida, United States | |
| United States, Illinois | |
| Investigational Site | |
| Chicago, Illinois, United States | |
| United States, Maryland | |
| Investigational Site | |
| Baltimore, Maryland, United States | |
| United States, Massachusetts | |
| Investigational Site | |
| Boston, Massachusetts, United States | |
| United States, Minnesota | |
| Investigational Site | |
| Minneapolis, Minnesota, United States | |
| United States, New Jersey | |
| Investigational Site | |
| Hackensack, New Jersey, United States | |
| United States, New York | |
| Investigational Site | |
| New York, New York, United States | |
| United States, Texas | |
| Investigational Site | |
| Dallas, Texas, United States | |
Sponsors and Collaborators
Zeltiq Aesthetics
More Information
No publications provided
| Responsible Party: | John Allison, VP Research, Development & Clinical Affairs, Zeltiq Aesthetics |
| ClinicalTrials.gov Identifier: | NCT00762437 History of Changes |
| Other Study ID Numbers: | ZA07005 |
| Study First Received: | September 27, 2008 |
| Last Updated: | June 16, 2011 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 23, 2013