NCT06934005

Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part II

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: UNEEG Medical A/S · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical investigation is to test the safety and performance of one short- and one long-term Baseplate constructed with different types of biocompatible adhesives.

Detailed description

This clinical investigation intended to test different biocompatible adhesives over time as part of the UNEEG Episight Baseplate construction for UNEEG™ medical A/S. The two Baseplates reported on in this registration, is a follow-up to an initial testing of four different types of adhesive i.e., four types of Baseplates. This study is Part II of the protocol. Part I is registered: NCT05111847

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DEVICE	Baseplate type A	Type A: Acrylate tested for 35 days behind one ear
DEVICE	Baseplate type C	Type C: Hydrocolloid tested for 35 days behind the other ear

Timeline

• Start date: 2022-08-22
• Primary completion: 2022-10-06
• Completion: 2022-10-06
• First posted: 2025-04-18
• Last updated: 2025-04-18

Locations

1 site across 1 country: Denmark