NCT05111847

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (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 short- and longterm Baseplates 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

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DEVICE	Short-term Baseplates first then long-term Baseplates	Short-term Baseplates A and B tested for 17/18 days first then long-term Baseplates C and D tested for 17/18 days
DEVICE	Long-term Baseplates first then short-term Baseplates	Long-term Baseplates C and D tested for 17/18 days first then short-term Baseplates A and B tested for 17/18 days

Timeline

• Start date: 2021-10-12
• Primary completion: 2022-06-23
• Completion: 2022-06-23
• First posted: 2021-11-08
• Last updated: 2026-01-14
• Results posted: 2026-01-14

Locations

1 site across 1 country: Denmark