Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Every subject will be treated 5 treatments , with 5+1 weeks interval.
研究概览
简要总结
The Intense Pulsed Light (IPL) technology, by selective phototermolysis, is used for eliminating, among other application, benign vascular lesions and unwanted leg veins. Light energy heats the deeper structures of the skin. IPL devices provide a broad wavelength spectrum of 515 to 1200 nm and fluence from 10 to 40 J/cm at o.5-1 Hz.The light is focused by a reflector and then transmitted through various filters that cut off the lower wavelength range of the emitted light; therefore, only those wavelengths longer than these of the filters are transmitted.
objectives:
- evaluate and optimize the clinical performance of the Luminis ONE platform for each of the aforementioned clinical applications.
- Reconfirm the parameter settings for each of the aforementioned clinical applications.
- Confirm the user friendly design of the device, in aspects of software (user interface) and various technical operational features.
详细描述
Background:
The Intense Pulsed Light (IPL) technology, by selective phototermolysis, is used for eliminating, among other application, benign vascular lesions and unwanted leg veins. Light energy heats the deeper structures of the skin. IPL devices provide a broad wavelength spectrum of 515 to 1200 nm and fluence from 10 to 40 J/cm at o.5-1 Hz.The light is focused by a reflector and then transmitted through various filters that cut off the lower wavelength range of the emitted light; therefore, only those wavelegths longer than these of the filters are transmitted.
Material and Methods:
The luminis ONE medical system (Lumenis Ltd., Yokneam,Israel, and Pleasanton, CA, USA) incorporate the non coherent pulsed light head.
Vascular lesion such as Telangiectases, leg veins or PWS will be treated with the IPL, with the following filters :515,50,or 590.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Subjects, presenting with at least one of the clinical indications mentioned above
- •Willing and being able to comply with all visit and evaluation requirements
- •Willing and being able to provide signed Informed Consent
排除标准
- •A history of keloid scar formation or poor wound healing
- •Wounded or tanned in area to be treated
- •Pregnant or intending to become pregnant during the evaluation period
- •Subjects with a bleeding disorder or who take anticoagulation medications
- •Significant concurrent illnesses, such as diabetes, epilepsy, lupus or congestive heart failure
- •Significant concurrent skin conditions affecting area to be treated
- •Having a history of skin cancer or any other cancer in the area to be treated
- •History of immunosuppressive disease
结局指标
主要结局
Every subject will be treated 5 treatments , with 5+1 weeks interval.
clearance or improvement will be evaluated by the physician at each visit,before the next treatment using the following scale:
1. No clearance
2. 0-25%
3. 25-50%
4. 50-75%
5. 75-100%
次要结局
未报告次要终点