Non-Invasive Reduction of Fat in the Arms With the CoolFlex Applicator

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics
ClinicalTrials.gov Identifier:
NCT01391923
First received: July 8, 2011
Last updated: March 15, 2012
Last verified: March 2012

July 8, 2011
March 15, 2012
July 2011
March 2012   (final data collection date for primary outcome measure)
Independent imaging review [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Performance will be evaluated by changes in the contour as established by blinded photographic review of a series of pre- and 16-week post-treatment images for each subject.
Same as current
Complete list of historical versions of study NCT01391923 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Non-Invasive Reduction of Fat in the Arms With the CoolFlex Applicator
Non-Invasive Reduction of Fat in the Arms With the CoolFlex Applicator

This study is being performed to reduce unwanted fat in the arm using a new applicator for the Zeltiq System.

The primary objective of the study is to evaluate the safety and performance of the CoolFlex applicator in the flat configuration for reduction of fat in the upper arms.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Fat Reduction in the Upper Arm
Device: The Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other Names:
  • Cryolipolysis
  • Lipolysis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female subjects > 18 years of age and < 65 years of age.
  2. Subject has clearly visible fat on the underside of the upper arm, generally located over the triceps muscle. (Figure 1)
  3. Subject has not had weight change exceeding 10 pounds in the preceding month.
  4. Subject agrees to maintain their weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
  5. Subject has read and signed a written informed consent form.

Exclusion Criteria:

  1. Subject has had a surgical procedure(s) in the area of intended treatment.
  2. Subject has had an invasive fat reduction procedure (e.g., liposuction or mesotherapy) in the area of intended treatment.
  3. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
  4. Subject needs to administer, or has a known history of, subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
  5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
  6. Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
  7. Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
  8. Subject body mass index (BMI) exceeds 40. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
  9. Subject is taking or has taken diet pills or supplements within the past month.
  10. Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation.
  11. Subject is pregnant or intending to become pregnant in the next 6 months.
  12. Subject is lactating or has been lactating in the past 6 months.
  13. Subject is unable or unwilling to comply with the study requirements.
  14. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
  15. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01391923
ZA11-002
No
Zeltiq Aesthetics
Zeltiq Aesthetics
Not Provided
Not Provided
Zeltiq Aesthetics
March 2012

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