Feasibility Study of a Belt Applicator
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|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.
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): 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|