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Pilot Study on The Flanks of Asian Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics
ClinicalTrials.gov Identifier:
NCT01623037
First received: June 14, 2012
Last updated: October 14, 2014
Last verified: June 2012

June 14, 2012
October 14, 2014
June 2012
October 2014   (final data collection date for primary outcome measure)
Efficacy [ Time Frame: 12 weeks post final treatment ] [ Designated as safety issue: No ]
• 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 ClinicalTrials.gov Archive Site
  • Ultrasound Measurements [ Time Frame: 12 weeks post final treatment ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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
PILOT STUDY OF NON-INVASIVE FAT LAYER REDUCTION IN THE FLANKS OF ASIAN PATIENTS WITH THE COOLCURVE+ APPLICATOR

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
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01623037
ZA12-006
No
Zeltiq Aesthetics
Zeltiq Aesthetics
Not Provided
Not Provided
Zeltiq Aesthetics
June 2012

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