Pilot Study of CoolTXT for Non-Invasive Fat Reduction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Body Fat Disorder
- Sponsor
- Zeltiq Aesthetics
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Efficacy Assessment through Ultrasound Measurements
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Efficacy Assessment through Ultrasound Measurements
Time Frame: 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 Outcomes
- Outcome Measured by Photo Review and Subject Satisfaction Questionnaire(16 weeks post final treatment)