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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01590368

Enrollment

Registered

2012-05-02

Start date

2012-06-30

Completion date

2012-06-30

Last updated

2012-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

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.

Interventions

DEVICEMarketed electrode

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

DEVICEModified test electrode

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026