Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part II
Phase: NA
Conditions: Healthy Subjects
Sponsor: UNEEG Medical A/S

 
 
 
2022-06-16 
 
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Clinical Investigation Plan 
U009 
Safety and performance of short- and long-term Baseplates  
for attaching the Marco Recorder  
(Brand name: UNEEG Episight) 
September 2021 - December 2022 
 
 

Clinical Investigation Plan - Marco Baseplate Study - U009 
 
 
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SYNOPSIS OF THE CLINICAL INVESTIGATION  
 
Title 
Duration 
Safety and performance of short- and long-
term Baseplates for attaching the Marco 
Recorder 
The study is divided into two parts. In the initial part 
(Main part/Part I) of the study, the inclusion period 
is up to 42 days for each subject, where the test 
period is divided into 2 periods of 17-18 days each. 
After the initial part of the study, an interim analysis 
will be performed and the result will be used to 
conduct a subsequent study period (Extension 
part/Part II) of up to 42 days including additional 
subjects. 
Introduction 
UNEEG™ medical is developing a new version of the 24/7 EEGTM SubQ system, which is used 
for ultra long-term ambulatory EEG recording. The current system consists of an implantable 
electrode and an external Recorder connected to a “disc” with a cable. The Recorder acts as a 
power source and data storage unit. When the disc is placed on the skin over the implant it 
receives a magnetic inductive link that 1) powers the electrode, and 2) transfers the recorded EEG 
signals to the Recorder. UNEEG™ medical is developing a new external power and storage unit 
with the in-house development name “Marco Recorder”, which is a smaller and cable-free 
replacement of the current version. The new Recorder is attached to the skin behind the ear by 
mounting it in a Baseplate consisting of a double adhesive and a plastic frame. 
The purpose of this clinical investigation is to test the safety and performance of short- and long-
term Baseplates constructed with different types of biocompatible adhesives. The short-term 
Baseplate must be replaced daily and the long-term every four days. The outcome of the 
investigation will be used by UNEEG™ medical to evaluate two Baseplates, one short-term and 
one long-term Baseplate, suitable for attaching the Marco Recorder to the skin behind the ear. 
Objective 
The primary objective of the study is to demonstrate the skin-friendliness of two types of 
Baseplates (i.e., adhesives) after  up to 35 days repeated use on the skin behind the ear. 
The secondary objectives are to 
• Demonstrate effectiveness of the Baseplate to hold the Recorder in place on the skin behind 
the ear. 
• Evaluate safety of the Baseplate (i.e., adhesives). 
• Evaluate subject-reported performance of the different types of Baseplates and the Recorder. 
• Evaluate subject-reported satisfaction. 
It is hypothesised that the various Baseplates can 1) hold a Recorder in place for 1 or up to 4 days 
depending on the type of adhesive, 2) be worn and removed gently without significantly irritating 
or damaging the skin. 
Endpoints 
Primary endpoint 
The trans epidermal water loss (TEWL) is captured to evaluate skin barrier functionality, i.e. to 
measure potential skin damage caused by repeated use of the Baseplate and Recorder. 
Secondary endpoints 

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Skin assessment endpoints 
• 
Hydration: An objective skin assessment based on conductance to measure the 
skin’s ability to retain water. 
• 
Erythema: An objective skin assessment based on reﬂectance spectrophotometry to 
measure reddening. 
• 
Pain upon removal is assessed by a Visual Analog Score (VAS) on a scale between 1-
10). 
• 
Skin condition is based on visual inspection by investigator (including a photo) and by 
subject -report. 
 
Safety endpoint 
• 
Nature and frequency of adverse events during the study and their severity, outcomes, 
and relationship to the Baseplate and Recorder. 
Performance & effectiveness endpoints (subject-reported) 
• 
Daily: Subject questionnaire on physical activity and complications with devices. 
• 
End of each test period: Subject questionnaire on user experience. 
User Satisfaction Endpoint 
• 
End of study: Subject satisfaction questionnaire. 
Design and Methods 
The first study part (Main part/Part I) is a randomised, controlled setup with an initial 2x2 cross-
over design consisting of two test periods of 17-18 days each. Thirty subjects will be included in 
this part, and each individual subject will test two short-term Baseplates (type A behind one ear 
and type B behind the other ear) in one test period (17-18 days) and two long-term Baseplates 
(type C and D) in a second test period of the same duration. The order of the two test periods 
(short/long-term Baseplate) and the site of attachment (left/right ear) will be randomised. Following 
this study part (Part I), an interim analysis will be performed to select the most promising short-
term and long-term Baseplate (i.e., adhesive) to be tested in the Extension part/Part II with a 
modified design. Thus, in the second study part (Extension part/Part II) 10 additional subjects will 
be included to test the selected Baseplates in a randomized controlled setup for a period of 35 
days.  
The study will take place in Denmark at Bispebjerg Hospital. 
Population/subjects 
The investigational population consists of 40 healthy subjects who comply with the following 
selection criteria: 
Inclusion Criteria: 
Exclusion 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 
• Have healthy skin behind the ear 
• Pregnant or breastfeeding1 
• 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 
 
1 Pregnancy is screened for through a pregnancy test before inclusion of fertile women. 

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Investigational device and comparator 
The investigational devices are non-CE marked biocompatible Baseplates and a non-functional 
Recorder. Four different Baseplates are identified as Baseplate A, B, C and D. Type A and B are 
tested for short-term (daily) use, and type C and D are tested for long-term (4 days) use. All types 
of Baseplates are biocompatible and intended for attaching other medical devices (1–4). 
Investigation approval  
The investigation will be approved by the local ethics committee (EC) and the regulatory authorities 
(LMS) in Denmark before initiating the investigation.