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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Subjects
• Intervention / Treatment: Device: Marketed electrode; Device: Modified "test" electrode

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Marketed electrode; The currently marketed electrodes using the current CE marked adhesive	Device: Marketed electrode; 12 electrodes will be placed on the subject for an ECG reading to be taken
ACTIVE_COMPARATOR: Modified hydrogel; Electrodes with the new modified adhesive - the "test" electrodes	Device: Modified "test" electrode; 12 electrodes with modified adhesive will be placed on the subject to allow an ECG reading to be taken

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Adverse Events	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	2 days
Skin Rating	Condition of the skin under the electrodes using the Skin Irritation Scale	2 days

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Investigators: Principal Investigator: Barbara A Schofield, North Cheshire Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ANTICIPATED): June 1, 2012
• Study Completion (ANTICIPATED): June 1, 2012

Study Registration Dates

• First Submitted: May 1, 2012
• First Submitted That Met QC Criteria: May 1, 2012
• First Posted (ESTIMATE): May 2, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 4, 2012
• Last Update Submitted That Met QC Criteria: May 2, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: UM-1015-12-U365