Status:

COMPLETED

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

Lead Sponsor:

UNEEG Medical A/S

Conditions:

Healthy Subjects

Eligibility:

All Genders

18-120 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 22 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 6 2022

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT06934005

Start Date

August 22 2022

End Date

October 6 2022

Last Update

April 18 2025

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Dermato-Venerologisk Afdeling og Videncenter for Sårheling, Bispebjerg Hospital

København NV, Denmark, 2400