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

Phase 3

• Conditions: Healthy Subjects
• Interventions: Device: Marketed electrode; Device: Modified "test" electrode

• Registration Number: NCT01590368
• Lead Sponsor: ConvaTec Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-05
• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-02
• Last Update Submitted: 2012-05-02
• Last Update Posted: 2012-05-04
• Study Start: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Marketed electrode	Marketed electrode	The currently marketed electrodes using the current CE marked adhesive
Modified hydrogel	Modified "test" electrode	Electrodes with the new modified adhesive - the "test" electrodes

Primary Outcome Measures

Name	Time	Method
Product Performance : Remain in place	30 minutes	Ability to remain in place for a duration of 30 minutes (as per intended use)
Product Performance: Perform	30 minutes	Ability of the electrodes to perform after a duration of 30 minutes of wear (ECG tracing) as per intended use.

Secondary Outcome Measures

Name	Time	Method
Safety: Adverse Events	2 days	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
Skin Rating	2 days	Condition of the skin under the electrodes using the Skin Irritation Scale