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Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis and hypodermis. Skin aging process involves among others: skin roughness (epidermis), skin dyschromia (epidermis, dermis), wrinkles and elastosis - skin texture changes due to collagen modification, skin laxity and cellulite (dermis and hypodermis).
EndyMed has developed the EndyMed Pro system - Computerized Radiofrequency System for Skin Tightening. By using a multielectrodes treatment tip an exact computerized thermal pattern can be produced allowing to selectively heating one or more of the target tissues (epidermis, dermis and hypodermis). In the skin tightening module the dermis and hypodermis would be targeted, creating enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis or dermis. This post marketing study is intended for evaluation of safety and efficacy of the EndyMed Pro system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Endymed study group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device: EndyMed Pro System for Skin Tightening | Device | Based on patient skin type and area of treatment the physician will choose the following parameters (some parameters are fixed): Pulse energy (J); RF frequency (1MHz); Pulse duration (30 sec); Treatment hand piece (skin tightening); |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of using the EndyMed Pro System for skin tightening will be established by physician's assessment/observation of adverse events (signs of pain, skin texture alterations or burn). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy endpoint of using the EndyMed Pro System for skin tightening will be established by level of skin tightness improvement. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Varda Godfried, Dr. | EndyMed Medical Ltd | Study Director |
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