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| Name | Class |
|---|---|
| Integrative Clinical Trials, LLC | UNKNOWN |
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The study will evaluate the measuring pulse rate (PR) using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).
The study design is to validate the pulse rate accuracy. The study is a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's pulse rate measurement compared to a reference heart rate manually measured by observing R-peaks in a standard concurrently recorded ECG from an FDA 510(k)-cleared reference clinical ECG (RCECG). The sponsor will ensure that the study staff enrolls a range of subjects.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norbert Device | Device | The Norbert Device (ND) is a contactless, noninvasive device that provides measurements of pulse rate. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Objective | To validate the accuracy specification for pulse rate from the ND when compared to an FDA-cleared medical device for heart rate monitoring electrocardiogram (ECG monitor, 5 lead). | Approximately 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy subjects 18 years of age or older with the ability to consent to study and follow instructions needed for data collection. Data will be collected on enrolled patients including but not limited to diabetes, hypertension, cardiac conditions, circulation problems, medications, and other health issues that would affect blood circulation to skin. Subject enrollment for these comorbidities and others will be based on incidental enrollment from the pool of available subjects per site.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Clinical Trials | Brooklyn | New York | 11229 | United States |
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