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

Study Overview
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Brief Summary
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It is hypothesised that the adhesion of electrodes and acceptability of the Electrocardiogram (ECG) trace is comparable between the two groups (marketed and test products) after 30 minutes (the intended period of use) of the electrodes.

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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Device: Marketed electrode
* Device: Modified test electrode


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent Be a healthy volunteer and be over 18 years of age Willing to attend two scheduled visits for application and removal of the device and adverse event review Have healthy unbroken skin Exclusion Criteria: Subjects with a history of sensitivity to any one of the components of the device being studied Subjects who have a history of skin related disorders to the chest. Subjects who are actively involved in the development, manufacturing, quality and marketing of Unomedical electrodes Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study Subjects who have any current cardiac conditions that may lead to an abnormal ECG trace
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Marketed electrode<br>The currently marketed electrodes using the current CE marked adhesive | Device: Marketed electrode<br>* 12 electrodes will be placed on the subject for an ECG reading to be taken<br>|
| Active Comparator: Modified hydrogel<br>Electrodes with the new modified adhesive - the test electrodes | Device: Modified test electrode<br>* 12 electrodes with modified adhesive will be placed on the subject to allow an ECG reading to be taken<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product Performance : Remain in place | Ability to remain in place for a duration of 30 minutes (as per intended use) | 30 minutes | 
| Product Performance: Perform | Ability of the electrodes to perform after a duration of 30 minutes of wear (ECG tracing) as per intended use. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Adverse Events | Safety will be evaluated by the nature and frequency of adverse events, (including condition of the skin under the electrodes using the Skin Irritation Scale (Appendix 4)) and ease of removal | 2 days | 
| Skin Rating | Condition of the skin under the electrodes using the Skin Irritation Scale | 2 days |