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

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-06-30

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.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Marketed electrode

The currently marketed electrodes using the current CE marked adhesive

Group Type OTHER

Marketed electrode

Intervention Type DEVICE

12 electrodes will be placed on the subject for an ECG reading to be taken

Modified hydrogel

Electrodes with the new modified adhesive - the "test" electrodes

Group Type ACTIVE_COMPARATOR

Modified "test" electrode

Intervention Type DEVICE

12 electrodes with modified adhesive will be placed on the subject to allow an ECG reading to be taken

Interventions

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Marketed electrode

12 electrodes will be placed on the subject for an ECG reading to be taken

Intervention Type DEVICE

Modified "test" electrode

12 electrodes with modified adhesive will be placed on the subject to allow an ECG reading to be taken

Intervention Type DEVICE

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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes