NCT02488083

UltraShape Device for Thigh Fat and Circumference Reduction vs. Control

Clinical Study to Evaluate the Performance of the UltraShape Device for Thighs Fat and Circumference Reduction vs. Control

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

Summary

UltraShape Device for Thigh Fat and Circumference Reduction: Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the UltraShape treatment for non-invasive fat and circumference reduction.

Detailed description

UltraShape Device for Thigh Fat and Circumference Reduction- Up to 60 healthy adult volunteers seeking for noninvasive thighs circumference reduction, male and females, 18 to 60 years of age from up to four investigational sites. Eligible subjects will receive 3 bi-weekly treatments (2 weeks interval) on one randomized thigh with the UltraShape device according to the study protocol. The other thigh will not be treated during the main study phase (and serve as control). The subjects will return for 3 follow up visits: four weeks (4wk FU), eight weeks (8wk FU) and 16 weeks (16wk FU) after the last treatment. Total expected study duration: 20-22 weeks. Should the subject choose to receive additional optional treatments on the untreated side, up to three bi-weekly treatments will be performed upon study completion at no cost to the subject while changing total study duration to 24-26 weeks.

Conditions

• Unwanted Thigh Fat

Interventions

Type	Name	Description
DEVICE	Ultrashape	circumference reduction

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-12-01
• Completion: 2017-03-01
• First posted: 2015-07-02
• Last updated: 2016-04-14

Locations

3 sites across 1 country: United States