A Multi-center Long Term Efficacy Trial of the GFX For Reduction of Glabellar Furrowing

Study Overview
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Brief Summary
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Long term efficacy study of GFX for patients undergoing reduction of glabellar furrowing

Detailed Description
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A Multi-center Long Term Efficacy Trial of GFX for the Reduction of Glabellar Furrowing

Official Title
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A Multi-center Long Term Efficacy Trial of the GFX For Reduction of Glabellar Furrowing

Conditions
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Glabellar Furrowing

Intervention / Treatment
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* Device: GFX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient will be included if: Has no medical contraindication Presents for correction of glabellar furrows, as classified per the Rated Numeric Kinetic Line Scale Score for Facial Wrinkles Secondary to Hyperkinetic Function (Class 1 or Higher) Is at least 18 years of age Signs a written informed consent Understands and accepts the obligation to present for scheduled follow-up visits Understands that the GFX procedure may not be successful Presents at the one month follow-up visit with an improvement from the base line RNKLS score Exclusion Criteria: The patient will be excluded if: Has had an injection of botulinum toxin to the target area within the previous 4 months and still exhibits a positive cosmetic effect to the glabellar frown. Has had silicone, fat, collagen or a synthetic material placed in the glabellar region or surgical correction or excision of the glabellar furrows Has a known bleeding disorder Pregnant Has received or is anticipated to receive anti-platelets, anti-coagulants, thrombolytics, or cancer therapy Is receiving systemic corticosteroids or anabolic steroids (standard doses of inhaled or nasal corticosteroids are acceptable) Has a history of chronic or recurrent infection or compromised immune system Has severe allergies manifested by a history of anaphylaxis Has known lidocaine hypersensitivity Is enrolled in another study Has history of keloid formation The investigator believes the patient is not a suitable candidate for the GFX procedure, or is not likely to receive cosmetic benefitPresents at the one month follow-up visit with no improvement from the base line RNKLS score

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients who have presented to the investigator for correction of glabellar furrows, as classified per the Rated Numeric Kinetic Line Scale Score for Facial Wrinkles Secondary to Hyperkinetic Function (Note: Class 1 or Higher)7 (Appendix R) are candidates for this study. | Device: GFX<br>* The GFX system employs minimally invasive technique utilizing Bi-polar (radio frequency) RF technology. GFX ablates nerves activating the muscles that cause glabellar furrowing.<br>* Other names: RF Nerve Ablation Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time at which the patient no longer shows an improvement from the base line RNKLS score indicating that the initially successful GFX procedure is no longer effective at a scheduled follow-up visit. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal or transient incidence of minor unanticipated adverse events. |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glabellar Furrowing