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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Device: Baseplate type A; Device: Baseplate type C

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 Type: Interventional
• Enrollment (Actual): 10
• 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: 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: Baseplate type A; Type A: Acrylate tested for 35 days behind one ear; Device: Baseplate type C; Type C: Hydrocolloid tested for 35 days behind the other ear

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 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.	35 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): August 22, 2022
• Primary Completion (Actual): October 6, 2022
• Study Completion (Actual): October 6, 2022

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: U009 Part II

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