Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder- Part I
概览
- 阶段
- 不适用
- 干预措施
- Short-term Baseplates first then long-term Baseplates
- 疾病 / 适应症
- Healthy Subjects
- 发起方
- UNEEG Medical A/S
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness
- 状态
- 已完成
- 最后更新
- 3个月前
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
研究者
入排标准
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
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
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)