Pilot Study on The Flanks of Asian Patients
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: June 14, 2012
Last updated: July 18, 2012
Last verified: June 2012
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||PILOT STUDY OF NON-INVASIVE FAT LAYER REDUCTION IN THE FLANKS OF ASIAN PATIENTS WITH THE COOLCURVE+ APPLICATOR|
Further study details as provided by Zeltiq Aesthetics:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Experimental: Fat Reduction||
Device: The Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
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