NCT02465762

UltraShape Device Using the U-Sculpt/VDF Transducer for Flanks Fat

Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Device Using the U-Sculpt/VDF Transducer for Flanks Fat and Circumference Reduction

• Status: Suspended
• 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 of the UltraShape treatment for non-invasive fat and circumference reduction. Study subjects will undergo UltraShape treatments on the flanks area using the U-Sculpt/VDF Transducer - 60 subjects.

Detailed description

This study is a prospective, baseline and blinded controlled, one arm clinical study showing the performance and safety of the UltraShape treatment for non-invasive fat and circumference reduction at the flanks area. 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 circumference and fat thickness will be measured and three successive bi-weekly (two weeks interval) UltraShape treatments will be performed. The study subjects will undergo UltraShape treatments on the flanks area using the U-Sculpt /VDF Transducer. During the follow-up period visit will be conducted as follow: 4 weeks (4wk FU), 8 weeks (8wk FU) and 16 weeks (16wk FU) post last treatment (Tx.3). Subject's circumference will be measured in the measurements points according to the flanks treated area, circumference reduction will be assessed at each visit. Additionally, a subject questionnaire will be completed in each follow-up visit. Finally, photography will be performed under visible light conditions of the front, right, left and back view. Most of the assessments will occur at each of the visits to the clinic.

Conditions

• Unwanted Flanks Fat

Interventions

Type	Name	Description
DEVICE	ultrashape Fat reduction	Ultrashape Device focused ultrasound to produce localized mechanical motion within fat tissues and cells for the purpose of producing mechanical cellular membrane disruption. It is intended for reduction in abdominal circumference.

Timeline

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