NCT01517646

Pilot Study of CoolTXT for Non-Invasive Fat Reduction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Zeltiq Aesthetics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Body Fat Disorder

Interventions

Type	Name	Description
DEVICE	The Zeltiq System	Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2012-01-25
• Last updated: 2017-06-22

Locations

1 site across 1 country: Canada