Evaluation of Thermal Outcome and Safety of Nuera Tight RF System

Study Overview
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Brief Summary
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The purpose of the study is to verify tissue heating, temperature stability and safety of the Nuera Tight RF device during and after treatment session applied on the face.

Official Title
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Evaluation of Thermal Outcome and Safety of Nuera Tight RF System

Conditions
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To Verify Tissue Heating and Temperature Stability and Safety Throughout RF Treatment Duration Applied on the Face

Intervention / Treatment
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* Device: NuEra Tight RF system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects of either gender, 18 years of age or older Subject is able to read, understand and sign an informed consent form Subject is willing to comply with all study procedures Exclusion Criteria: Subjects taking medicines that increase skin sensitivity to heat Subjects taking medicines that change skin metabolism Cancer or any pigmentary or vascular lesions in the planned treatment area Subjects with Herpes simplex in the area to be treated Pregnant women Subjects wearing pacemakers and/or any other type of implanted electronics Subjects with any inflammatory skin conditions Subjects with active cold sores, open lacerations, abrasions Chronic or acute skin infections Subjects with active local or systemic infections Subjects with any disease in which an increase of skin temperature is contraindicated Subjects wearing piercing in the area to be treated Subjects have nerve insensitivity to heat in the area to be treated Subjects have metal implants in the area to be treated, excluding dental implants Subjects allergic to glycerin, paraffin, parfum, parabens, nuts, vegetable oils, calendula, or chamomile Any condition where the study investigator determined that the subject is not adequate for this study Subjects participating in other studies

Ages Eligible for Study
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Minimum Age: 18 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nuera Tight RF System<br>Subjects will receive an RF treatment session on the periorbital area and cheeks with a frequency of 1 and 4 MHz. Each subject will be treated on one side of the face using a 10 mm capacitive electrode, and on the other side using a 20 mm capacitive electrode. The target temperature will be set at 42 C. | Device: NuEra Tight RF system<br>* monopolar radiofrequency device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tissue heating | To verify tissue heating throughout the treatment duration applied on the face. The temperature will be set at 42 C, the operator will move the electrode in a continuous motion until the skin temperature reached the target temperature, then the treatment will continue for another 12 minutes. the skin temperature will be measured using an infrared thermometer to verify tissue heating | 12 minutes | 
| temperature stability | To verify temperature stability throughout the treatment duration applied on the face. the skin temperature will be measured using an infrared thermometer every 3 minutes to verify temperature stability | 12 minutes |