Clinical Study To Assess The Safety, Parameters And Efficacy For Procedures Using A Radiofrequency Device

Study Overview
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Brief Summary
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The purpose of this study was to develop parameters and assess the safety of the radiofrequency device for a variety of treatments. Treatment results were also evaluated.

Official Title
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Clinical Study To Assess The Safety, Parameters And Efficacy For Procedures Using A Radiofrequency Device

Conditions
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Tissue Heating, Coagulation

Intervention / Treatment
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* Device: TempSure
* Device: Scalpel
* Device: Bovie
* Device: Pelleve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A healthy male or female 18 years of age or older. 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 child bearing 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 course of the study. The subject has active or localized systemic infections. 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 prior to entering this study. Any other types of cosmetic treatments in the area to be treated in the past 6 months are cautioned and determined at the discretion of the investigator. The subject has a history of keloids. The subject has evidence of active systemic or local skin disease that may alter wound healing. The subject has scarring or wounds in the treatment area that would interfere with study assessments. The subject has a metal implant (such as but not limited to; titanium orbit or metal chin repair) in the face or head that would interfere with study treatment, or subject has an electronic implantable device (such as but not limited to; pacemakers and embedded defibrillators). 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.

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical- abdominoplasty<br>Subjects enrolled in the surgical arm were treated with the device being placed in contact with the skin on the abdomen. The hand piece, number of passes and parameters used for the treatment were determined by the Investigator. | Device: TempSure<br>* Radiofrequency platform<br>Device: Scalpel<br>* Cold knife<br>Device: Bovie<br>* Electrosurgery and electrocautery platform<br>|
| Experimental: Women's Health<br>Subjects enrolled in the women's health were treated with the device in the vaginal and perineal area. | Device: TempSure<br>* Radiofrequency platform<br>|
| Experimental: Skin Rejuvenation<br>The hand piece, applicator or tip was placed in contact with the skin. The entire defined treatment area was treated by delivering energy to the skin. The hand piece, number of passes and parameters used for the treatment was determined by the Investigator. | Device: TempSure<br>* Radiofrequency platform<br>Device: Pelleve<br>* Radiofrequency platform<br>|
| Experimental: Surgical- blepharoplasty<br>Subjects enrolled in the surgical arm were treated with the device being placed in contact with the skin on the eyelids. The hand piece, number of passes and parameters used for the treatment were determined by the Investigator. | Device: TempSure<br>* Radiofrequency platform<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Satisfaction | The subject will be asked their level of satisfaction using a 6-point Likert scale that ranges from extremely satisfied to extremely unsatisfied, with 1 being extremely unsatisfied and 6 being extremely satisfied. | 30 days post final treatment | 
| Number of Tissue Samples With Successful Results | This is the number of tissue samples removed by the device (on 1 subject) that has similar histological results to scalpels and cautery devices currently on the market. | Immediately Post Treatment (Same Day) |