Pilot Study of CoolTXT for Non-Invasive Fat Reduction
This study is being performed to reduce unwanted fat, in various body areas, using a new applicator and control unit for Zeltiq.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Pilot Study of CoolTXT for Non-Invasive Fat Reduction|
- Efficacy Assessment through Ultrasound Measurements [ Time Frame: 16 weeks post final treatment ] [ Designated as safety issue: No ]
The primary endpoint will be analyzed by percent reduction in fat layer thickness, as measured by ultrasound.
• Safety endpoint: incidence of device- or procedure-related adverse events. Acceptance criteria - zero incidences of UADEs.
- Outcome Measured by Photo Review and Subject Satisfaction Questionnaire [ Time Frame: 16 weeks post final treatment ] [ Designated as safety issue: No ]
- Comparison of pre- and 16-week post final treatment photographs of the treatment area(s).
- Subject satisfaction as assessed by questionnaires administered at 16 weeks post final treatment.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (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.
The purpose of this study is to evaluate the safety and feasibility of a new product under development for non-invasive fat reduction. The new product delivers controlled cooling via a conformable surface applicator, rather than the existing vacuum applicator. A range of treatment parameters will be investigated. At the investigator's discretion, each treatment area may receive up to 3 treatments, spaced 2 - 8 weeks apart. The subjects will return for follow-up at 2 months and 4 months after final treatment. Therefore, the entire study period may last up to 8 months.