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NCT05111847 Clinical Trial

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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05111847
Other study ID # U009
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 12, 2021
Est. completion date October 6, 2022

Study information
Verified date November 2023
Source UNEEG Medical A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date October 6, 2022
Est. primary completion date October 6, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Baseplates with two types of adhesives are tested: 3M 1522 & Nitto ST-2410WD
Baseplates with two different types of adhesives are placed behind the ears; One baseplate with one of the two types of the adhesive behind each ear
• Baseplates with two types of adhesives are tested: Amparo 130002 & 3M 2480
Baseplates with two different types of adhesives are placed behind the ears; One baseplate with one of the two types of the adhesive behind each ear

Locations
Country Name City State
Denmark Dermato-Venerologisk Afdeling og Videncenter for Sårheling, Bispebjerg Hospital København NV

Sponsors (1)
Lead Sponsor Collaborator
UNEEG Medical A/S

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Trans epidermal water loss (TEWL) to measure skin-friendliness To evaluate the skin barrier functionality (i.e., skin-friendliness) after repeated use of two types of Baseplates (i.e., adhesives) on the skin behind the ear. up to 35 days
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