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|
|Body Fat Disorder||Device: The Zeltiq System|
|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|
|Primary Completion Date :||October 2014|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|