NCT02489994

Performance of the ePrime System for Cellulite

Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of Cellulite

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Syneron Medical · Industry
• Sex: Female
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of Cellulite.

Detailed description

Up to 60 healthy adult volunteers seeking cellulite treatment, females of 25 to 60 years of age, from multiple investigational sites. This is an open-label, multi-center study. Subjects in this study will receive a single subcutaneous treatment with the ePrime device in one treatment session according to the study protocol. Prior to treatments, tissue to be treated will be injected with tumescence or local dermal infiltration solution according to the protocol. Subjects will return for follow-up (FU) visits at: 1 week, 1 month, 3 months and 6 months following the treatment. Methodology described in protocol to evaluate efficacy of treatments will be carried out at each visit.

Conditions

• Cellulite

Interventions

Type	Name	Description
DEVICE	ePrime	The main intent of the ePrime for cellulite is to utilize a minimally-invasive approach to directly deliver RF energy into tissue through pairs of micro-electrode needles and use temperature sensors within the needles to reliably create fractional thermal injuries within the skin.

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-08-01
• Completion: 2016-10-01
• First posted: 2015-07-03
• Last updated: 2016-03-18

Locations

4 sites across 1 country: United States