NCT02465775

Fat Reduction in the Flanks Area vs. Control

Clinical Study to Evaluate the Performance of the UltraShape Device for Fat Reduction Treatment in the Flanks Area 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

Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation the performance of the UltraShape treatment for non-invasive fat reduction by compare control and treated flanks. Study subjects will undergo UltraShape treatments on one randomized flank using the U-Sculpt/VDF Transducer. The second flank will not be treated (control). Both flanks (treated and control) will be compared to baseline, as well as, one to each other

Detailed description

This study is a prospective, baseline and blinded controlled, comparison, clinical study showing the performance and safety of the UltraShape treatment for non-invasive fat reduction at the flanks area comparing improvement observed in treated versus control flanks. Up to 60 Healthy subjects in up to 4 investigational sites will be enrolled in this study. All subjects will undergo an assessment of their general health. During the treatment period, subject's fat thickness will be measured on both flanks. Three successive bi-weekly (two weeks interval) UltraShape treatments will be performed on one randomized flank, while the second flank will not be treated and served as a control. The study subjects will undergo UltraShape treatments on one flank using the U-Sculpt /VDF Transducer, the treated flank will remain steady along the study and will be comparing to the baseline and to the controlled flank Three follow-up visits will be conducted as follows: 4 weeks (4wk FU), 8 weeks (8wk FU) and 16 weeks (16wk FU) post last treatment (Tx.3). Subject's fat thickness will be measured on both flanks in the measurements points using caliper at each visit (at treatment visits, prior to treatment). Ultrasound measurements will be taken at each visit, except for the second treatment visit, on each flank. Investigator satisfaction will be assessed at all FU visits. In addition, subject questionnaires will be completed at each follow-up visit. Photographs of the front, right, left and back view of each flank will be performed under visible light conditions at each study visit.

Conditions

• Flanks Fat Reduction vs. Control

Interventions

Type	Name	Description
DEVICE	UltraShape treatment	Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-09-01
• Completion: 2017-12-01
• First posted: 2015-06-08
• Last updated: 2016-04-14

Locations

3 sites across 1 country: United States