NCT04584099

Multi-Center Traditional Feasibility Study of Radiofrequency Device

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Cynosure, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Body Fat

Interventions

Type	Name	Description
DEVICE	Radiofrequency device treatment	TempSure firm

Timeline

• Start date: 2020-08-25
• Primary completion: 2021-01-14
• Completion: 2021-01-14
• First posted: 2020-10-12
• Last updated: 2023-06-15
• Results posted: 2023-06-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study