Non-Invasive Reduction of Fat in the Inner Thighs
|ClinicalTrials.gov Identifier: NCT01517659|
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : June 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Body Fat Disorder||Device: The Zeltiq System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-Invasive Reduction of Fat in the Inner Thighs With the Zeltiq Coolsculpting System|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
|No Intervention: Fat Reduction||
Device: The Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
- Efficacy and Safety [ Time Frame: 16 weeks post treatment ]
- Efficacy endpoint: correct identification of pre-treatment vs. 16-week post-treatment images by three masked independent reviewers. Success will be defined as at least 80% correct identification of the pre-treatment images.
- Safety endpoint: measurement of device- or procedure-related adverse events.
- Subject Satisfaction [ Time Frame: 16 weeks post final treatment ]Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517659
|United States, California|
|Laser & Skin Surgery Center of Northern California|
|Sacramento, California, United States, 95816|
|United States, Minnesota|
|Zel Skin and Laser Specialists|
|Edina, Minnesota, United States, 55424|
|United States, Texas|
|Dallas Plastic Surgery Institute|
|Dallas, Texas, United States, 75231|
|Principal Investigator:||Suzanne Kilmer, MD||Laser and Skin Surgery Center of Northern California|