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The need for cosmetic facial enhancement procedures with minimal down time and low risk has led to the development of methods for non-surgical skin rejuvenation. Various ablative lasers were developed, which remove the full skin surface in a controlled manner. However, the prolonged recovery and the significant risks prompted the development of fractional lasers which ablate the skin in a fractional manner, leaving untreated areas to improve healing process. In the past few years, fractional RF systems have been introduced that enable controlled skin resurfacing accompanied with dermal collagen remodeling. System using focused ultrasound , coagulating small volume of tissue in the dermis , have shown a lifting effect.8 Similar to these devices the EndyMed Proâ„¢ System with RF Micro-Needles handpiece (INTENSIF) enables fractional skin coagulation with dermal heating for the reduction of wrinkles together with a lifting effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RF ablation treatment | Experimental | 'EndyMed Proâ„¢ RF Micro-Needles' - RF ablation treatments for wrinkle appearance reduction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndyMed Proâ„¢ RF Micro-Needles | Device | RF Micro-needles ablation treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of the EndyMed ProTM Intensif handpiece for wrinkle reduction and lifting, measured by Adverse events occurrence | Adverse events occurrence | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of the EndyMed ProTM Intensif handpiece for wrinkle reduction and lifting, measured by wrinkle appearance reduction | wrinkle appearance reduction | 5 months |
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanna Levy, Dr | Contact | +972-52-2824966 | hanna@qsitemed.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael Gold, Dr | Tennessee Clinical Research Center, Nashville, Tennessee, USA | Principal Investigator |
| Mark Taylor, Dr | Gateway Aesthetic Institute and Laser Center, Salt Lake City, Utah, USA | Principal Investigator |
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| Kenneth Rothaus, Dr | Ageless Plastic Surgery, New York, NY, USA | Principal Investigator |
| Yohei Tanaka, Dr | Clinica Tanaka Plastic and Reconstructive Surgery and Anti-aging Center, Tokyo, Japan | Principal Investigator |