Feasibility Study of a Belt Applicator
|ClinicalTrials.gov Identifier: NCT01767142|
Recruitment Status : Completed
First Posted : January 14, 2013
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 :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of a Belt Applicator for Non-Invasive Fat Reduction in the Outer Thigh|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
|Experimental: Fat Reduction||
Device: The Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
- Effectiveness [ Time Frame: 16 weeks post final treatment ]Effectiveness endpoint: percent reduction in fat layer thickness, as measured by ultrasound.
- Photographs pre and 16-week post [ Time Frame: 16 weeks post final treatment ]Comparison of pre- and 16-week post treatment photographs of the treatment area(s) for discernible reduction in treatment area(s).
- Subject Satisfaction [ Time Frame: 16 weeks post 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): NCT01767142
|United States, California|
|Marina Plastic Surgery|
|Marina del Rey, California, United States, 90292|
|Innovation Research Center|
|Pleasanton, California, United States, 94588|
|Principal Investigator:||Eric Bachelor, MD||Innovation Research Center|