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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Marketed electrode | Other | The currently marketed electrodes using the current CE marked adhesive |
|
| Modified hydrogel | Active Comparator | Electrodes with the new modified adhesive - the "test" electrodes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marketed electrode | Device | 12 electrodes will be placed on the subject for an ECG reading to be taken |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara A Schofield | North Cheshire Hospital | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 9, 2012 | |
| Reset | Nov 7, 2012 | |
| Release | Jul 29, 2013 | |
| Reset | Aug 29, 2013 | |
| Release | Sep 2, 2013 | |
| Reset | Nov 4, 2013 | |
| Release | Feb 6, 2014 | |
| Reset | Mar 28, 2014 | |
| Release | Apr 20, 2017 | |
| Reset | May 23, 2017 | |
| Release | Dec 20, 2017 | |
| Reset | Jan 22, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 9, 2012 | Nov 7, 2012 | |||
| Jul 29, 2013 |
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| Modified "test" electrode | Device | 12 electrodes with modified adhesive will be placed on the subject to allow an ECG reading to be taken |
|
Condition of the skin under the electrodes using the Skin Irritation Scale
| 2 days |
| Aug 29, 2013 |
| Sep 2, 2013 | Nov 4, 2013 |
| Feb 6, 2014 | Mar 28, 2014 |
| Apr 20, 2017 | May 23, 2017 |
| Dec 20, 2017 | Jan 22, 2018 |