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A study to collect data recorded by devices for cNIBP evaluation purposes.
The study is going to be conducted to collect data from the devices used in the study for future AMS engineering purposes as deemed appropriate by the Sponsor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambulatory monitoring solution | Experimental | this study has only one arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| measuring blood pressure with noninvasive blood pressure device | Device | To measure blood pressure in different circumstances with noninvasive blood pressure device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Data collection of NIBP measurement | To collect data recorded by devices for cNIBP evaluation purposes. | through study completion, average of one day |
| 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. | through study completion, an average of one day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juha Pärkkä | Contact | +35840-7530525 | juha.parkka@vtt.fi |
| Name | Affiliation | Role |
|---|---|---|
| Juha Pärkkä | VTT | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 12, 2022 | |
| Reset | Nov 29, 2022 | |
| Release | Oct 31, 2024 | |
| Reset | Dec 17, 2024 | |
| Release | Jun 4, 2025 | |
| Reset | Jun 18, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 12, 2022 | Nov 29, 2022 | |||
| Oct 31, 2024 |
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| Dec 17, 2024 |
| Jun 4, 2025 | Jun 18, 2025 |