Non-Invasive Cooling of Fat Cells

This study has been completed.

Sponsor:

Information provided by:

Zeltiq Aesthetics

ClinicalTrials.gov Identifier:

NCT00762437

First received: September 27, 2008

Last updated: June 16, 2011

Last verified: May 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	September 27, 2008
Last Updated Date	June 16, 2011
Start Date ^ICMJE	January 2008
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 30, 2008)	Visible improvement in treated area [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: September 29, 2008)	Visible improvement in treated area based on photographic assessment of treated area versus the untreated control [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00762437 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 30, 2008)	Subject satisfaction [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: September 29, 2008)	Subject satisfaction as determined by completion of a questionnaire [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Non-Invasive Cooling of Fat Cells
Official Title ^ICMJE	Not Provided
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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Reduction of Unwanted Fat
Intervention ^ICMJE	Device: Zeltiq Dermal Cooling Device Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
Study Arm (s)	Experimental: 1 Intervention: Device: Zeltiq Dermal Cooling Device
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	240
Completion Date	June 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00762437
Other Study ID Numbers ^ICMJE	ZA07005
Has Data Monitoring Committee	No
Responsible Party	John Allison, VP Research, Development & Clinical Affairs, Zeltiq Aesthetics
Study Sponsor ^ICMJE	Zeltiq Aesthetics
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Zeltiq Aesthetics
Verification Date	May 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top