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| Name | Class |
|---|---|
| IPPMed, Institute for Pharmacology and Preventive Medicine GmbH | UNKNOWN |
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Up to 185 adult test subjects to evaluate blood pressure measurement accuracy and stability of the Polsoâ„¢ Watch compared to a reference blood pressure measurement.
The purpose of this validation study is to assess, in an adult population, the three fundamental clinical tests:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polsoâ„¢ Watch blood pressure measurement compared to a reference blood pressure measurement | Experimental | Mean difference between the Polsoâ„¢ Watch and reference measurement, and the associated standard deviation using data from the rest and induced change measurements following initialization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polsoâ„¢ Watch blood pressure measurement compared to a reference blood pressure measurement | Device | The referenced blood pressure measurements are taken by dual auscultators. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Objectives: Main objective of the study is to evaluate blood pressure measurement accuracy and stability of the Polsoâ„¢ Watch compared to a reference blood pressure measurement over time frame of 1 month average. | Blood pressure measurements (units: mmHg) using the Polsoâ„¢ Watch device will be taken and compared to reference blood pressure measurements taken at the same time using dual auscultatory blood pressure measurements, to show their accuracy and stability. | Through study completion, 1 month average |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IPPMed - Institute for Pharmacology and Preventive Medicine GmbH | Cloppenburg | Low Saxony | 49661 | Germany |
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