NCT02143960

VelaShape III Device in Comparison to Cryolipolysis for Circumferential Reduction

Clinical Study to Evaluate the Performance of the VelaShape III Device in Comparison to Cryolipolysis for Reduction in Waist / Love Handles / Flanks.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Syneron Medical · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the clinical performance of the VelaShape III device with CoolSculpt for reduction of the waist, love handles and flanks.

Detailed description

VelaShape is a non-invasive (not breaking the skin) device for Body Reshaping and Cellulite Treatment. VelaShape combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation. The CoolSculpt System is a noninvasive device that reduces fat by freezing fat cells until they break apart.

Conditions

• Abdominal Fat

Interventions

Type	Name	Description
DEVICE	VelaShape III	Subjects will receive one treatment to their entire waist / love-handle/ flanks area in a split-waist fashion, so that one side is treated with one device and the other side is treated with the other device. The treatment session will include: one side (right or left) treated with the VelaShape III device and the other side (left or right, respectively) with the CoolSculpt device. The subject will be randomized to one of 2 treatment groups, one will receive treatment to the left side with the VelaShape II and the right side will receive treatment with the CoolSculpt. The other group will receive treatment to right side with the VelaShape II and the left side will receive treatment with the CoolSculpt.
DEVICE	CoolSculpt	Noninvasive Cryolipolysis

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-05-21
• Last updated: 2014-12-02

Locations

1 site across 1 country: United States