Feasibility Study of a Belt Applicator
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: January 9, 2013
Last updated: September 27, 2013
Last verified: January 2013
Evaluate the safety and feasibility of non-invasive fat reduction in the outer thigh with a belt applicator. Applicator design and treatment parameters will be evaluated.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Feasibility Study of a Belt Applicator for Non-Invasive Fat Reduction in the Outer Thigh|
Further study details as provided by Zeltiq Aesthetics:
Primary Outcome Measures:
- Effectiveness [ Time Frame: 16 weeks post final treatment ] [ Designated as safety issue: No ]Effectiveness endpoint: percent reduction in fat layer thickness, as measured by ultrasound.
Secondary Outcome Measures:
- Photographs pre and 16-week post [ Time Frame: 16 weeks post final treatment ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Subject satisfaction as assessed by questionnaires administered at 16 weeks post treatment.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Experimental: 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: NCT01767142
|United States, California|
|Marina Plastic Surgery|
|Marina del Rey, California, United States, 90292|
|Innovation Research Center|
|Pleasanton, California, United States, 94588|
Sponsors and Collaborators