This study is being performed to reduce unwanted fat, in various body areas, using a new applicator and control unit for Zeltiq.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
18
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Arbutus Laser Centre
Vancouver, British Columbia, Canada
Efficacy Assessment through Ultrasound Measurements
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.
Time frame: 16 weeks post final treatment
Outcome Measured by Photo Review and Subject Satisfaction Questionnaire
* 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.
Time frame: 16 weeks post final treatment
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