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

UNEEG medical

Status: Completed

Conditions: Healthy Subjects

Treatments: Device: Long-term Baseplates first then short-term Baseplates; Device: Short-term Baseplates first then long-term Baseplates

Study type: Interventional

Funder types: Industry

Identifiers

NCT05111847

U009 Part I

Details and patient eligibility

About

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.

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

Enrollment: 34 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Short-term Baseplates first then long-term Baseplates

Other group

Description:

Short-term Baseplates - Type A: Acrylate Type B: YUKI-gel Long-term Baseplates - Type C: Hydrocolloid Type D: Silicone

Treatment:

Device: Short-term Baseplates first then long-term Baseplates

Long-term Baseplates first then short-term Baseplates

Other group

Description:

Long-term Baseplates - Type C: Hydrocolloid Type D: Silicone Short-term Baseplates - Type A: Acrylate Type B: YUKI-gel

Treatment:

Device: Long-term Baseplates first then short-term Baseplates