Personalized Interactive Laser Therapy of Port Wine Stain - Study 2
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation.
研究概览
简要总结
Lasers are being used to treat Port Wine Stains (PWS), but the laser doesn't always work. Only about 10% of PWS can be completely cleared. The research team believes that the investigators can improve the response of PWS to laser therapy by using a computer program that the principal investigator of this study (Dr. Shafirstein PhD) has developed. The purpose of this study is to test the validity of this computer program. Personalized Interactive Laser Therapy (PILT) could significantly improve clinical outcomes of laser treatment of PWS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with a PWS
- •At least one visible PWS measuring greater than or equal to 15 mm in diameter.
- •Information provided regarding alternative treatment methods, includig no treatment.
- •Reading, understanding, and signing of an informed consent document.
- •Children age 7 years or older has read, understood, and signed an assent document.
- •Agreement to participate in the study.
- •Agreement to return to at least 1 follow-up evaluation and treatment within 1 year after first treatment.
- •Zubrod performance status of 0 or 1 at screening.
排除标准
- •Inability or unwillingness of subject to participate in the study.
- •Inability or unwillingness of one parent or legal guardian of the subject to sign written informed consent document.
- •Subject can not return to at least 1 follow-up visit within 1 year, after the first treatment.
结局指标
主要结局
Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation.
时间窗: Three treatments up to one year, whichever is first
6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.
次要结局
未报告次要终点