Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part II

Not Applicable

Completed

• Conditions: Healthy Subjects

• Registration Number: NCT06934005
• Lead Sponsor: UNEEG Medical A/S

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 Timeline

• Study Start: 2022-08-22
• Primary Completion: 2022-10-06
• Study Completion: 2022-10-06
• Study First Submitted: 2025-03-12
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Trans epidermal water loss (TEWL) to measure skin-friendliness	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.

Trial Locations

Locations (1)

Dermato-Venerologisk Afdeling og Videncenter for Sårheling, Bispebjerg Hospital; 🇩🇰 København NV, Denmark