Non-invasive Cooling of Subcutaneous Fat

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics
ClinicalTrials.gov Identifier:
NCT00762307
First received: September 27, 2008
Last updated: January 4, 2012
Last verified: January 2012

September 27, 2008
January 4, 2012
January 2007
January 2012   (final data collection date for primary outcome measure)
Reduction in the fat layer thickness [ Time Frame: 2 months, 6 months ] [ Designated as safety issue: No ]
Reduction in the fat layer thickness as demonstrated by measurement of fat thickness [ Time Frame: 2 months, 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00762307 on ClinicalTrials.gov Archive Site
Subject satisfaction [ Time Frame: 2 months, 6 months ] [ Designated as safety issue: No ]
Subject satisfaction as determined by completion of a questionnaire [ Time Frame: 2 months, 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Non-invasive Cooling of Subcutaneous Fat
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
192
January 2012
January 2012   (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 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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00762307
JM07001
No
Zeltiq Aesthetics
Zeltiq Aesthetics
Not Provided
Not Provided
Zeltiq Aesthetics
January 2012

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