Multi-Center Traditional Feasibility Study of Radiofrequency Device

Body Fat Clinical Trial

Official title: Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-invasive Lipolysis

Status Terminated

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 abdominal area.

Clinical Trial Description

Subjects are to be enrolled in this clinical study if they are 18 - 55 years old and are willing to have biopsies taken from a control site and the treatment area. Subjects may be enrolled if they have been previously scheduled or willing to have an abdominoplasty procedure after their participation in the study. A maximum of 20 subjects will be enrolled at up to 4 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments with the TempSure® Firm on the abdomen or flanks. All subjects will receive a phone call 1 week (1-10 days) post each treatment. Subjects may be asked to return for follow-up visits after their final treatment for incisional biopsies. A follow up may occur at 10, 20, and/or 30 days post their last treatment. ;

Related Conditions & MeSH terms

• Body Fat

• NCT number: NCT04584099
• Study type: Interventional
• Source: Cynosure, Inc.
• Status: Terminated
• Phase: N/A
• Start date: August 25, 2020
• Completion date: January 14, 2021