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

Convatec

Status and phase: Unknown; Phase 3

Conditions: Healthy Subjects

Treatments: Device: Modified "test" electrode; Device: Marketed electrode

Study type: Interventional

Funder types: Industry

Identifiers

NCT01590368

UM-1015-12-U365

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Marketed electrode

Other group

Description:

The currently marketed electrodes using the current CE marked adhesive

Treatment:

Device: Marketed electrode

Modified hydrogel

Active Comparator group

Description:

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

Treatment:

Device: Modified "test" electrode