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The present study, OBPM_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational system together with several reference systems within a cohort of subjects characterized by a wide variety of phenotypes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring | Other | All study participants will test the investigational device (Aktiia G2C) and other marketed devices for blood pressure and pulse rate measurements (Aktiia Bracelet G2, Double auscultation, oscillometric monitors, finger pulse oximeter). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational device Aktiia G2C | Device | Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia G2C. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of study subjects that contribute with analyzable raw data collected | Min 85 study subjects contribute with analyzable raw data collected | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure mean value of differences | The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements. | 1 hour |
| Blood pressure standard deviation of differences |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grégoire Wuerzner, Medical Doctor Prof. | Contact | +41213140223 | gregoire.wuerzner@chuv.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUV | Recruiting | Lausanne | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41514019 | Derived | Zahnd J, Thompson B, Rigon PA, Taffe P, Wuerzner G. Comparison of two validated oscillometric devices in a home-like setup reveals pronounced blood pressure differences and reduced precision. Hypertens Res. 2026 Mar;49(3):969-973. doi: 10.1038/s41440-025-02514-3. Epub 2026 Jan 9. |
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1 study cohort that will test investigational device (Aktiia G2C) and Blood Pressure and Pulse Rate references.
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| Marketed device used as reference for blood pressure monitoring: double auscultation cuff | Device | Study subjects are asked to stay seated and relaxed while successive measurements are taken with cuff for double auscultation. |
|
| Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2 | Device | Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia Bracelet G2. |
|
| Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff | Device | Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric upper-arm cuff. |
|
| Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff | Device | Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric wrist cuff. |
|
| Marketed device used as reference for pulse rate monitoring: pulse finger oximeter | Device | Study subjects are asked to stay seated and relaxed while successive measurements are taken with pulse finger oximeter. |
|
The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements.
| 1 hour |
| Pulse rate root-mean-square error | The root-mean-square difference between the Aktiia G2C pulse rate determinations and the reference method. | 1 hour |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001794 | Blood Pressure |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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