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)
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1
Dermato-Venerologisk Afdeling og Videncenter for Sårheling, Bispebjerg Hospital
København NV, Denmark, 2400