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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-22

Study Completion Date

2022-10-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05111847

Healthy Subjects

COMPLETED NA

A Comparative Wear Test of Two Adhesives on the Unilect ™ Biotab Short Term Monitoring Electrode

NCT01590368

Healthy Subjects

UNKNOWN PHASE3

Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers

NCT01292941

Spinal Cord Injury

WITHDRAWN PHASE1

Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line

NCT00804453

Chronic Kidney Failure

COMPLETED NA

Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy Volunteers

NCT02965105

Incontinence, Urinary

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Following a cross-over design in Part I of the study, two of the four initial Baseplates, is tested for longer wear time (35 days) in this Part II of the study.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Short-term Baseplate A and long-term Baseplate C, concomitant use

All participants wore Short-term Baseplate A behind one are and long-term Baseplate C behind the other ear for 35 days.

Group Type OTHER

Baseplate type A

Intervention Type DEVICE

Type A: Acrylate tested for 35 days behind one ear

Baseplate type C

Intervention Type DEVICE

Type C: Hydrocolloid tested for 35 days behind the other ear

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Baseplate type A

Type A: Acrylate tested for 35 days behind one ear

Intervention Type DEVICE

Baseplate type C

Type C: Hydrocolloid tested for 35 days behind the other ear

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes