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

November 20, 2023 updated by: UNEEG Medical A/S
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • København NV, Denmark, 2400
        • Dermato-Venerologisk Afdeling og Videncenter for Sårheling, Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Short-term Baseplate
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
Active Comparator: Long-term Baseplate
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trans epidermal water loss (TEWL) to measure skin-friendliness
Time Frame: up to 35 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNEEG Medical A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2021

Primary Completion (Actual)

October 6, 2022

Study Completion (Actual)

October 6, 2022

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

October 26, 2021

First Posted (Actual)

November 8, 2021

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • U009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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