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

Sponsor
UNEEG Medical A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05111847
Collaborator
(none)
35
Enrollment
1
Location
2
Arms
12.6
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Safety and Performance of Short- and Long-term Baseplates for Attaching the Marco Recorder
Actual Study Start Date :
Oct 12, 2021
Anticipated Primary Completion Date :
Oct 20, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Trans epidermal water loss (TEWL) to measure skin-friendliness [17-18 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dermato-Venerologisk Afdeling og Videncenter for Sårheling, Bispebjerg Hospital København NV Denmark 2400

Sponsors and Collaborators

  • UNEEG Medical A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
UNEEG Medical A/S
ClinicalTrials.gov Identifier:
NCT05111847
Other Study ID Numbers:
  • U009
First Posted:
Nov 8, 2021
Last Update Posted:
May 25, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 25, 2022