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

UNEEG medical

Status

Completed

Conditions

Healthy Subjects

Treatments

Device: Baseplate type A

Device: Baseplate type C

Study type

Interventional

Funder types

Industry

Identifiers

NCT06934005

U009 Part II

Details and patient eligibility

About

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.

Full 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

Enrollment

10 patients

Sex

All

Ages

18 to 120 years old

Volunteers

Accepts Healthy Volunteers

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