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A study to evaluate the operational and functional features of the Ambulatory Monitor Solution (AMS) as well as the ease of use of the system.
The study is going to be conducted to collect feedback from the users about operation of AMS collect parameter raw data from patients in hospital ward setting using the investigational system for use in current and future AMS engineering and regulatory purposes as deemed appropriate by the Sponsor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambulatory Monitoring Solution | Experimental | The evaluable device is a secondary monitoring device and no decisions/diagnosis will be made from these devices. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory monitoring solution | Device | Subjects participating in this study will be monitored with the site's standard of care primary monitor and the evaluable device as the secondary monitor. |
| Measure | Description | Time Frame |
|---|---|---|
| User feedback survey about the use of the Ambulatory Monitoring Solution | The feedback from the clinical users about operational features, alarms, user experience and ease of use of Ambulatory Monitoring Solution will be collected. | 5 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Collect number of adverse events (AEs), serious adverse events (SAEs), and device issues | The safety objective is to collect safety information, including type and number of adverse events (AE), serious adverse events (SAE), and device issues. The descriptive statistical methods will be used to analyze AE and SAE data. | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meera Joshi, MBBS | St. Marys Hospital, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chelsea and Westminster Hospital | London | SW10 9NH | United Kingdom |
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