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

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ClinicalTrials.gov Identifier: NCT01590368
Recruitment Status : Unknown
Verified May 2012 by ConvaTec Inc..
Recruitment status was:  Not yet recruiting
First Posted : May 2, 2012
Last Update Posted : May 4, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Device: Marketed electrode Device: Modified "test" electrode Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Comparative Wear Test of Two Adhesives on the Unilect ™ Biotab Short Term Monitoring Electrode
Study Start Date : June 2012
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Product Performance : Remain in place [ Time Frame: 30 minutes ]
    Ability to remain in place for a duration of 30 minutes (as per intended use)

  2. Product Performance: Perform [ Time Frame: 30 minutes ]
    Ability of the electrodes to perform after a duration of 30 minutes of wear (ECG tracing) as per intended use.


Secondary Outcome Measures :
  1. Safety: Adverse Events [ Time Frame: 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

  2. Skin Rating [ Time Frame: 2 days ]
    Condition of the skin under the electrodes using the Skin Irritation Scale


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590368


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

Responsible Party: ConvaTec Inc.
ClinicalTrials.gov Identifier: NCT01590368     History of Changes
Other Study ID Numbers: UM-1015-12-U365
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2012