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.
Device: Marketed electrode
Device: Modified "test" electrode
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Full eligibility criteria for NCT01590368
Ages eligible for Study
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT01590368
View full eligibility
Tris trial is registered with FDA with number: NCT01590368. The sponsor of the trial is ConvaTec Inc. and it is looking for 20 volunteers for the current phase.
Official trial title: A Comparative Wear Test of Two Adhesives on the Unilect ™ Biotab Short Term Monitoring Electrode
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