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

This study is not yet open for participant recruitment.
Verified May 2012 by ConvaTec Inc.
Sponsor:
Information provided by (Responsible Party):
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT01590368
First received: May 1, 2012
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
 Device: Marketed electrode
Device: Modified "test" electrode
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Comparative Wear Test of Two Adhesives on the Unilect ™ Biotab Short Term Monitoring Electrode

Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:
  • Product Performance : Remain in place [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Ability to remain in place for a duration of 30 minutes (as per intended use)

  • Product Performance: Perform [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Ability of the electrodes to perform after a duration of 30 minutes of wear (ECG tracing) as per intended use.


Secondary Outcome Measures:
  • Safety: Adverse Events [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Condition of the skin under the electrodes using the Skin Irritation Scale


Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590368

Sponsors and Collaborators
ConvaTec Inc.
Investigators
Principal Investigator: Barbara A Schofield North Cheshire Hospital
  More Information

No publications provided

Responsible Party: ConvaTec Inc.
ClinicalTrials.gov Identifier: NCT01590368     History of Changes
Other Study ID Numbers: UM-1015-12-U365
Study First Received: May 1, 2012
Last Updated: May 2, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on May 19, 2013