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Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM)
Sponsor: Aktiia SA
Summary
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.
Official title: Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM) Algorithm That Requires No Calibration with an External Cuff: a Single-center Prospective Clinical Study
Key Details
Gender
All
Age Range
21 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
85
Start Date
2024-06-25
Completion Date
2025-12-31
Last Updated
2024-12-17
Healthy Volunteers
Yes
Conditions
Interventions
Investigational device Aktiia G2C
Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia G2C.
Marketed device used as reference for blood pressure monitoring: double auscultation cuff
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
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
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
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
Study subjects are asked to stay seated and relaxed while successive measurements are taken with pulse finger oximeter.
Locations (1)
CHUV
Lausanne, Switzerland