Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 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 one short- and one long-term Baseplate 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.
The two Baseplates reported on in this registration, is a follow-up to an initial testing of four different types of adhesive i.e., four types of Baseplates.
This study is Part II of the protocol. Part I is registered: NCT05111847
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
结局指标
主要结局
Trans epidermal water loss (TEWL) to measure skin-friendliness
时间窗: 35 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 equates to unhealthy skin = high loss of water that passes from inside a body through the epidermis.High levels of TEWL equates to unhealthy skin = high loss of water that passes from inside a body through the epidermis.
次要结局
未报告次要终点