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

September 27, 2008
June 16, 2011
January 2008
June 2011   (final data collection date for primary outcome measure)
Visible improvement in treated area [ Time Frame: 4 months ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00762437 on ClinicalTrials.gov Archive Site
Subject satisfaction [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Subject satisfaction as determined by completion of a questionnaire [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Non-Invasive Cooling of Fat Cells
Not Provided

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Reduction of Unwanted Fat
Device: Zeltiq Dermal Cooling Device
Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
Experimental: 1
Intervention: Device: Zeltiq Dermal Cooling Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00762437
ZA07005
No
John Allison, VP Research, Development & Clinical Affairs, Zeltiq Aesthetics
Zeltiq Aesthetics
Not Provided
Not Provided
Zeltiq Aesthetics
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP