Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part II
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- UNEEG Medical A/S
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Trans epidermal water loss (TEWL) to measure skin-friendliness
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Short-term Baseplate A and long-term Baseplate C, concomitant use
All participants wore Short-term Baseplate A behind one are and long-term Baseplate C behind the other ear for 35 days.
Intervention: Baseplate type C (Device)
Short-term Baseplate A and long-term Baseplate C, concomitant use
All participants wore Short-term Baseplate A behind one are and long-term Baseplate C behind the other ear for 35 days.
Intervention: Baseplate type A (Device)
Outcomes
Primary Outcomes
Trans epidermal water loss (TEWL) to measure skin-friendliness
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported