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

NCT05111847 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-01-14

Study results available
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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.

Conditions

  • Healthy Subjects

Interventions

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

Sponsors & Collaborators

  • UNEEG Medical A/S

    lead INDUSTRY

Principal Investigators

  • Tonny Karlsmark, Dr. · Bispebjerg Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2022-06-23
Completion
2022-06-23

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05111847 on ClinicalTrials.gov