NCT02748928

UltraShape Power for Abdominal Fat and Circumference Reduction

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Syneron Medical · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Prospective, one arm, baseline-controlled, clinical study for the evaluation of the UltraShape Power treatment using the U-Sculpt Power Transducer for non-invasive abdominal fat and circumference reduction.

Detailed description

Up to 120 healthy adult volunteers, seeking noninvasive abdominal fat and circumference reduction, male and females, 18 to 60 years of age from 6 investigational sites. Eligible subjects will receive 3 bi-weekly treatments (2 weeks interval) with the UltraShape Power device utilizing the U-Sculpt Power Transducer according to the study protocol. Subjects will return for 3 follow-up visits: four weeks (4wk FU), eight weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment (Third Treatment). Each subject will be enrolled for total expected study duration of 16 weeks. Subject's abdominal fat thickness and circumference will be measured at 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 Power	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: 2016-06-08
• Primary completion: 2017-02-15
• Completion: 2018-04-23
• First posted: 2016-04-22
• Last updated: 2019-03-19
• Results posted: 2019-03-07

Locations

8 sites across 1 country: United States