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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01590368
• Other study ID #: UM-1015-12-U365
• Status: Unknown status
• Phase: Phase 3
• First received: May 1, 2012
• Last updated: May 2, 2012
• Start date: June 2012
• Est. completion date: June 2012

Study information

• Verified date: May 2012
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Device:
• Marketed electrode
12 electrodes will be placed on the subject for an ECG reading to be taken
• Modified "test" electrode
12 electrodes with modified adhesive will be placed on the subject to allow an ECG reading to be taken

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ConvaTec Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Product Performance : Remain in place	Ability to remain in place for a duration of 30 minutes (as per intended use)	30 minutes
Primary	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	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
Secondary	Skin Rating	Condition of the skin under the electrodes using the Skin Irritation Scale	2 days