Pilot Study of CoolTXT for Non-Invasive Fat Reduction
- Conditions
- Body Fat Disorder
- Registration Number
- NCT01517646
- Lead Sponsor
- Zeltiq Aesthetics
- Brief Summary
This study is being performed to reduce unwanted fat, in various body areas, using a new applicator and control unit for Zeltiq.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Efficacy Assessment through Ultrasound Measurements 16 weeks post final treatment 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.
- Secondary Outcome Measures
Name Time Method Outcome Measured by Photo Review and Subject Satisfaction Questionnaire 16 weeks post final treatment * 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.
Trial Locations
- Locations (1)
Arbutus Laser Centre
🇨🇦Vancouver, British Columbia, Canada
Arbutus Laser Centre🇨🇦Vancouver, British Columbia, Canada