NCT02154113

Ultrashape System in Combination With VelaShape II Device for Circumferential Reduction

Baseline Controlled Two-arm Multi-Center Study to Evaluate the Safety and Efficacy of Combined Multi-Focus Treatments of UltraShape® Contour I V3 System and VelaShape II Device for Non-Invasive Circumference Reduction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Syneron Medical · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the clinical performance of the Ultrashape system with VelaShape II device for reduction of the waist.

Detailed description

UltraShape® Contour I V3 system is a non-invasive (not breaking the skin) focused ultrasound for body contouring purposesdesigned to selectively disrupt sub-dermal fat cells employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves, remain intact. There are no thermal effects. Fat-cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time. VelaShape is a non-invasive device for Body Reshaping and Cellulite Treatment. VelaShape combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation.

Conditions

• Abdominal Fat

Interventions

Type	Name	Description
DEVICE	Ultrashape	All subjects receive 3 successive Ultrashape treatments every two weeks in the anterior abdomen.
DEVICE	Velashape II	All subjects receive 3 successive Velashape treatments every two weeks in the anterior abdomen.

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2014-06-03
• Last updated: 2014-06-03

Locations

2 sites across 1 country: Canada