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

UNEEG medical

Status: Completed

Conditions: Healthy Subjects

Treatments: Device: Baseplates with two types of adhesives are tested: 3M 1522 & Nitto ST-2410WD; Device: Baseplates with two types of adhesives are tested: Amparo 130002 & 3M 2480

Study type: Interventional

Funder types: Industry

Identifiers

NCT05111847

U009

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.

Enrollment: 44 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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44 participants in 2 patient groups

Short-term Baseplate

Active Comparator group

Treatment:

Device: Baseplates with two types of adhesives are tested: 3M 1522 & Nitto ST-2410WD

Long-term Baseplate

Active Comparator group

Treatment:

Device: Baseplates with two types of adhesives are tested: Amparo 130002 & 3M 2480