Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder- Part I
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness
研究概览
简要总结
The purpose of this clinical investigation is to test the safety and performance of short- and longterm Baseplates constructed with different types of biocompatible adhesives.
详细描述
This clinical investigation intended to test different biocompatible adhesives over time as part of the UNEEG Episight Baseplate construction for UNEEG™ medical A/S
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent obtained, and letter of authority signed before any study related activities
- •Are at least 18 years of age and have full legal capacity
- •Healthy skin behind the ear
排除标准
- •Pregnant or breastfeeding
- •Known allergic responses to the adhesives
- •Treatment with corticosteroids, either as a cream in the area behind the ear or systemically (tablet or injection) within the last month
- •Subject is unable or does not have the necessary assistance to properly operate the device system
研究组 & 干预措施
Short-term Baseplates first then long-term Baseplates
Short-term Baseplates - Type A: Acrylate Type B: YUKI-gel
Long-term Baseplates - Type C: Hydrocolloid Type D: Silicone
干预措施: Short-term Baseplates first then long-term Baseplates (Device)
Long-term Baseplates first then short-term Baseplates
Long-term Baseplates - Type C: Hydrocolloid Type D: Silicone
Short-term Baseplates - Type A: Acrylate Type B: YUKI-gel
干预措施: Long-term Baseplates first then short-term Baseplates (Device)
结局指标
主要结局
Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness
时间窗: 17-18 days
To evaluate the skin barrier functionality (i.e., skin-friendliness) after repeated use of Baseplates (i.e., adhesives) on the skin behind the ear. High levels of TEWL reflects unhealthy skin, i.e. high loss of water that passes from inside a body through the epidermis.
次要结局
- Skin Reactions(17-18 days)