Pilot Study on The Flanks of Asian Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01623037
Recruitment Status : Completed
First Posted : June 19, 2012
Last Update Posted : June 22, 2017
Information provided by (Responsible Party):
Zeltiq Aesthetics

June 14, 2012
June 19, 2012
June 22, 2017
June 2012
October 2014   (Final data collection date for primary outcome measure)
Efficacy [ Time Frame: 12 weeks post final treatment ]
• Correct identification of pre-treatment vs. 12-week post-treatment images by three blinded independent reviewers.
Same as current
Complete list of historical versions of study NCT01623037 on Archive Site
  • Ultrasound Measurements [ Time Frame: 12 weeks post final treatment ]
    • Reduction in the fat layer thickness, as demonstrated by comparison of pre-treatment and 12-week post-treatment caliper measurements.
  • Subject Satisfaction Questionnaire [ Time Frame: 12 weeks post final treatment ]
    • Subject satisfaction as assessed by questionnaire administered at 12-week post-treatment.
    • Operator feedback on the fit of the device via a questionnaire at treatment visit.
Same as current
Not Provided
Not Provided
Pilot Study on The Flanks of Asian Patients
The purpose of this study is to evaluate the performance of the CoolCurve+ applicator for non-invasive fat layer reduction in flanks for Asian patient population.
Not Provided
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Body Fat Disorder
Device: The Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other Names:
  • Cryolipolysis
  • Lipolysis
Experimental: Fat Reduction
Intervention: Device: The Zeltiq System
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2014
October 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria

  • Male or female subjects > 18 years of age.
  • Subjects must be of Asian descent.
  • Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
  • Subject has not had weight change exceeding 10 pounds in the preceding month.
  • Subject with body mass index (BMI) up to 25. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
  • Subject with sharp flank curvature that fits well with the CoolCurve+ applicator.
  • Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
  • Subject has read and signed a written informed consent form.

Exclusion Criteria

  • Subject has had a surgical procedure(s) in the area of intended treatment.
  • Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment.
  • Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
  • 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.
  • Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
  • 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.
  • 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.
  • Subject is taking or has taken diet pills or supplements for weight loss within the past month.
  • 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 (stretch marks is not an exclusion).
  • Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
  • Subject is pregnant or intending to become pregnant during the study period (in the next 4 months).
  • Subject is lactating or has been lactating in the past 6 months.
  • Subject is unable or unwilling to comply with the study requirements.
  • Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
  • 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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Plan to Share IPD: No
Zeltiq Aesthetics
Zeltiq Aesthetics
Not Provided
Principal Investigator: Henry Chan, MD Hong Kong Dermatology and Laser Centre
Zeltiq Aesthetics
June 2012

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