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

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermato-Venerologisk Afdeling og Videncenter for Sårheling, Bispebjerg Hospital

København NV, 2400, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baseplate type A

Device

Type A: Acrylate tested for 35 days behind one ear

Baseplate type C

Device

Type C: Hydrocolloid tested for 35 days behind the other ear

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.

Sponsors and collaborators

Lead sponsor

UNEEG Medical A/S

Industry

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Apr 18, 2025
Registry last updated: Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed