NCT02700152

Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Device for Non-Invasive Abdominal Fat Reduction

• 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 of the UltraShape treatment for non-invasive abdominal fat reduction. Study subjects will undergo UltraShape treatments on the abdominal area

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 abdominal fat reduction. 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 and circumference will be measured and three successive UltraShape treatments, two weeks interval, will be performed. The study subjects will undergo UltraShape treatments on the abdomen. During the follow-up period visit will be conducted as follow: 4 weeks (4wk FU), 8 weeks (8wk FU) and 12 weeks (12wk FU) post last treatment (Tx.3). Subject's abdominal fat thickness and circumference will be measured in the measurements points and will be assessed at each visit. Additionally, a subject questionnaire will be completed in each follow-up visit (4wk, 8wk and 12wk FU). 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 (all treatments and all follow-up visits) to the clinic.

Conditions

• Excess Abdominal Fat

Interventions

Type	Name	Description
DEVICE	UltraShape	Tissue selectivity is achieved by a proprietary knowledge of ultrasound parameters ensuring specific destruction of the fat cells only within the target area. 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

Timeline

• Start date: 2016-01-01
• Primary completion: 2020-06-01
• Completion: 2020-11-01
• First posted: 2016-03-07
• Last updated: 2018-02-19

Locations

2 sites across 1 country: United States