Multi-Center Pivotal Study of Radiofrequency Device

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Body Fat

Intervention / Treatment
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* Device: TempSure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |