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Completed

NCT Number: NCT05111847

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.

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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

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

Short-term Baseplates first then long-term Baseplates

Device

Short-term Baseplates A and B tested for 17/18 days first then long-term Baseplates C and D tested for 17/18 days

Long-term Baseplates first then short-term Baseplates

Device

Long-term Baseplates C and D tested for 17/18 days first then short-term Baseplates A and B tested for 17/18 days

Primary outcomes

  1. Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness

    Time frame: 17-18 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 reflects unhealthy skin, i.e. high loss of water that passes from inside a body through the epidermis.

Secondary outcomes

  1. Skin Reactions

    Time frame: 17-18 days

    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)

Sponsors and collaborators

Lead sponsor

UNEEG Medical A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 8, 2021
Registry last updated
Jan 14, 2026

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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