Performance of the ePrime System for Cellulite

Cellulite Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cellulite

• NCT number: NCT02489994
• Study type: Interventional
• Source: Syneron Medical
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2014
• Completion date: October 2016