Evaluation of Safety and Efficacy of Using EndyMed Pro Skin Treatment System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- 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).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females age 30 and up
- •Subjects with Fitzpatrick 4 to 9 degrees of elastosis
- •Subject able to comprehend and give informed consent for participation in this study
- •Subject must commit to all treatments and follow-up visits
- •Subject must sign the Informed Consent Form
排除标准
- •Subjects with implanted pacemakers, arrhythmias or any other severe known heart disorder
- •Subjects with any implantable metal device in the treatment area
- •Subjects on any medication that would affect the characteristic of the skin (medical or hormonal), such as "Accutane", within the past 6 months
- •Subjects that have had any other invasive or non invasive method of skin therapy or hair removal performed in the past 6 months (in the treated area)
- •Subjects who are scheduled or planned for any other invasive or non invasive method of skin therapy or hair removal in the treatment area at the period of the study
- •Subjects who have any form of suspicious lesion on the treatment area
- •Subjects with history of keloid formations or hypertrophic scarring
- •Pregnant or lactating Subjects
- •Subjects with Epilepsy or severe migraines
- •Subjects with permanent makeup/ tattoo/ body piercing (in the treated area)
- •Subjects with any Infection / abscess / pains in treatment target area
- •Eczema or dermatitis
- •Subjects who suffer from autoimmune disorders or diabetes
- •Subjects using blood thinning medications
- •Subjects with clotting disorders
- •Subjects on drugs or psychologically determined unsuitable for the study
- •Subject is suffering extreme general weakness
- •Subject objects to the study protocol
- •Concurrent participation in any other clinical study
- •Physician objection
结局指标
主要结局
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).
时间窗: 3 months
次要结局
- Efficacy endpoint of using the EndyMed Pro System for skin tightening will be established by level of skin tightness improvement.(3 months)