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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-12

Study Completion Date

2022-06-23

Brief Summary

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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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Detailed Description

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This clinical investigation intended to test different biocompatible adhesives over time as part of the UNEEG Episight Baseplate construction for UNEEG™ medical A/S

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

In Part I of the study, the baseplates type A, B, C and D were tested on the skin behind the ears. Each subject tested either 1) short-term baseplates A and B first for 17/18 days and then long-term baseplates C and D for 17/18 days or 2) long-term baseplates C and D first for 17/18 days and then short-term baseplates A and B for 17/18 days.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Short-term Baseplates first then long-term Baseplates

Short-term Baseplates - Type A: Acrylate Type B: YUKI-gel

Long-term Baseplates - Type C: Hydrocolloid Type D: Silicone

Group Type OTHER

Short-term Baseplates first then long-term Baseplates

Intervention Type 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

Long-term Baseplates - Type C: Hydrocolloid Type D: Silicone

Short-term Baseplates - Type A: Acrylate Type B: YUKI-gel

Group Type OTHER

Long-term Baseplates first then short-term Baseplates

Intervention Type 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

Interventions

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Short-term Baseplates first then long-term Baseplates

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

Intervention Type DEVICE

Long-term Baseplates first then short-term Baseplates

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes