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

U

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

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)

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

Trial contacts and locations

1

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Central trial contact

Kristine Latocha, PhD; Louise B Johansen, PhD

Data sourced from clinicaltrials.gov

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