Multi-Center Pivotal Study of Radiofrequency Device

NCT04569253 | Completed Results FDA Device

• 1 other identifier: CYN20-FIRM-LIPO
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Body Fat

Outcome Measures

Primary Outcomes (1)

• % 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

Study Arms (1)

All study participants

EXPERIMENTAL

Subjects will receive treatments with the RF device on one flank. The other flank will be left untreated to serve a control.

Device: TempSure

Interventions

TempSure DEVICE

Non-invasive radiofrequency treatments

All study participants

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (6)

Maryland Dermatology Laser, Skin, & Vein Institute, LLC.

Hunt Valley, Maryland, 21030, United States

Location

JUVA Skin & Laser Center

New York, New York, 10022, United States

Location

Jeremy A Brauer MD PC

Rye, New York, 10580, United States

Location

Saluja Cosmetic and Laser Center

Huntersville, North Carolina, 28078, United States

Location

Dermatology Associates of Plymouth Meeting, P.C.

Plymouth Meeting, Pennsylvania, 19462, United States

Location

McDaniel Institute of Anti-Aging Research

Virginia Beach, Virginia, 23462, United States

Location

Related Publications (1)

• 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.

  PMID: 31896400 BACKGROUND

Results Point of Contact

• Title: Jamie Trimper
• Organization: Cynosure

jamie.trimper@cynosure.com

(978) 256-4200

Study Officials

• Jennifer Civiok

  Cynosure, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 29, 2020
• Study Start: July 28, 2020
• Primary Completion: March 26, 2021
• Study Completion: March 26, 2021
• Last Updated: June 14, 2022
• Results First Posted: June 14, 2022

Record last verified: 2022-06

Locations

US (6)