Multi-Center Pivotal Study of Radiofrequency Device

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

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.

Study Overview

• Status: Completed
• Conditions: Body Fat
• Intervention / Treatment: Device: TempSure

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Hunt Valley, Maryland, United States, 21030
      • Maryland Dermatology Laser, Skin, & Vein Institute, LLC.
  • New York
    • New York, New York, United States, 10022
      • Juva Skin & Laser Center
    • Rye, New York, United States, 10580
      • Jeremy A Brauer MD PC
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Saluja Cosmetic and Laser Center
  • Pennsylvania
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Dermatology Associates of Plymouth Meeting, P.C.
  • Virginia
    • Virginia Beach, Virginia, United States, 23462
      • McDaniel Institute of Anti-Aging Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A healthy male or female between the age of 18 - 55 years old.
• Willing to undergo treatments for fat reduction of the flank area (love handle)
• Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
• Understands and accepts the obligation and is logistically able to be present for all visits.
• Is willing to comply with all requirements of the study and sign the informed consent document

Exclusion Criteria:

• Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
• The subject has a cut, wound, or infected skin on the area to be treated.
• The subject is on local, oral, or systemic anesthetic agents.
• The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
• The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.

Cautionary Criteria:

• The subject has any embedded electronic device that gives or receives a signal, the device should be turned off or removed prior to treatment.
• The subject has an embedded pacemaker or implantable cardioverter defibrillator (ICD), the client's cardiologist must be consulted prior to treatment.

NOTE: This device has not been tested on patients implanted with electronic devices that receive or emit signals, such as: Pacemakers, Implantable Cardiac Defibrillators (ICD), or Cardiac Resynchronization Therapy (CRT) devices.

• If the neutral pad would need to be placed on a subject that has a metal plate, rod, or any metal implant that could conduct heat from the Smart Handpiece or surgical handpiece.
• The subject is allergic to adhesives, such as glues on medical tape, they should be alerted that a rash may occur on the neutral pad site and an over the counter solution may be used to treat the area.
• The subject is allergic to gold, such as the metallic covering of the TempSure handpieces.
• The subject is allergic to corn, such as the corn derivative ingredient in Parker Aquasonic Gel.
• If the subject has an unhealthy expectation of the results - this is not plastic surgery and all subject should be fully informed of the treatment's expected results.
• The subject has nerve insensitivity to heat in the treatment area.
• The subject has severe laxity or sagging that causes redundant folds of tissue or hanging skin in the area to be treated - this treatment will be ineffective.
• The subject has used Accutane (Isotretinoin) six to twelve months prior to treatment, as this can thin the skin and make it brittle.
• Studies of the use of the RF generator on subjects that have any of the following conditions is unknown:

Autoimmune Disease Diabetic Herpes Simplex

• Use caution when treating areas that have scars, tattoos, permanent makeup, and permanent brows.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All study participants; Subjects will receive treatments with the RF device on one flank. The other flank will be left untreated to serve a control.	Device: TempSure; Non-invasive radiofrequency treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of Photos Identified Correctly When Comparing 12 Week Follow Up to Baseline	Correct identification of pre-treatment images vs. the 12-week follow up images by blinded evaluators.	12 Week Follow Up

Collaborators and Investigators

• Sponsor: Cynosure, Inc.
• Investigators: Study Director: Jennifer Civiok, Cynosure, Inc.

Publications and helpful links

General Publications

• Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2020
• Primary Completion (Actual): March 26, 2021
• Study Completion (Actual): March 26, 2021

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CYN20-FIRM-LIPO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes