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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Device: Short-term Baseplates first then long-term Baseplates; Device: Long-term Baseplates first then short-term Baseplates

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

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • København NV, Denmark, 2400
    • Dermato-Venerologisk Afdeling og Videncenter for Sårheling, Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Device: Short-term Baseplates first then long-term Baseplates; Short-term Baseplates A and B tested for 17/18 days first then long-term Baseplates C and D tested for 17/18 days
Other: 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	Device: Long-term Baseplates first then short-term Baseplates; Long-term Baseplates C and D tested for 17/18 days first then short-term Baseplates A and B tested for 17/18 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness	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.	17-18 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Reactions	Systematic assessment (visual inspection by investigator and self-reporting by participant via daily questionnaires). Some skin reactions were also reported as adverse device effects (see Adverse Event section)	17-18 days

Collaborators and Investigators

• Sponsor: UNEEG Medical A/S
• Investigators: Study Chair: Tonny Karlsmark, Dr., Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Actual): June 23, 2022
• Study Completion (Actual): June 23, 2022

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: U009 Part I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No