NCT03502473

UltraShape Power Device for Fat Reduction in Flanks

Clinical Assessment to Evaluate UltraShape Power Device Performance for Flanks Fat Reduction

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Syneron Medical · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Prospective, baseline-controlled evaluation of the UltraShape Power device for non-invasive fat reduction in flanks.

Detailed description

Eligible subjects will receive 3 bi-weekly treatments (2 weeks interval) with the UltraShape Power device according to the study protocol. One random flank will be treated with one pass or remained as a control (no treatment) while the second flank will be treated with multiple passes. Subjects will return for up to 4 follow up visits: 4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks following end of treatment/s. Each subject will be enrolled for total expected study duration of up to 28 weeks. After last follow up visit, subjects who wish will receive compensation treatments (up to 3) on the flank who received regular treatment (single pass) or remained as a control (no treatment).

Conditions

• Excess Abdominal Fat

Interventions

Type	Name	Description
DEVICE	UltraShape Power device	UltraShape Power is a non-invasive focused ultrasound device, approved by the FDA (160896K;170370K); CE; Israeli Ministry of Health. The UltraShape Power system works by emitting acoustic waves of focused ultrasonic energy (200 ± 30 KHz frequency) that converge into a confined focal volume underneath the skin, thereby, targeting only subcutaneous fat at a controlled depth. Unlike traditional ultrasound technology, UltraShape Power's energy transmits pulsed ultrasound, allowing control over temperature elevation. The system comprised of two main parts: * The Main console * Transducer

Timeline

• Start date: 2018-03-07
• Primary completion: 2019-03-07
• Completion: 2019-09-07
• First posted: 2018-04-18
• Last updated: 2020-01-06

Locations

1 site across 1 country: Israel