Non-Invasive Reduction of Fat in the Inner Thighs
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: January 17, 2012
Last updated: January 28, 2014
Last verified: November 2012
Evaluate the safety and efficacy of non-invasive fat reduction in the inner thighs with the ZELTIQ CoolSculpting System.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Non-Invasive Reduction of Fat in the Inner Thighs With the Zeltiq Coolsculpting System|
Resource links provided by NLM:
Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Schindler disease succinic semialdehyde dehydrogenase deficiencyU.S. FDA Resources
Further study details as provided by Zeltiq Aesthetics:
Primary Outcome Measures:
- Efficacy and Safety [ Time Frame: 16 weeks post treatment ] [ Designated as safety issue: No ]
- 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.
Secondary Outcome Measures:
- Subject Satisfaction [ Time Frame: 16 weeks post final treatment ] [ Designated as safety issue: No ]Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
|No Intervention: Fat Reduction||
Device: The Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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|
Sponsors and Collaborators