Multi-Center Pivotal Study of Radiofrequency Device

Body Fat Clinical Trial

Official title: Clinical Study to Assess the Safety and Efficacy of the Tempsure® Firm for Non-invasive Lipolysis of the Flanks.

Status Completed

Clinical Trial Summary

This is a prospective, controlled, multi-center study. Patients will be enrolled and treated with a radiofrequency device in this study if they have unwanted fat in the flank (love handle) area.

Clinical Trial Description

Subjects are to be enrolled in this clinical study if they are 18 - 55 years old. A maximum of 55 subjects will be enrolled at up to 6 study centers. Subjects will receive up to 5 treatments with the TempSure® Firm on one flank. The other flank will be left untreated to serve a control. Subject will be required to return for follow-up visits at 6 weeks and at 12 weeks after the subject's final treatment. All subjects will receive a phone call 1 week (1-10 days) post each treatment. ;

Related Conditions & MeSH terms

• Body Fat

• NCT number: NCT04569253
• Study type: Interventional
• Source: Cynosure, Inc.
• Status: Completed
• Phase: N/A
• Start date: July 28, 2020
• Completion date: March 26, 2021