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OBPM_PANDA2026: Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring Device
Sponsor: Aktiia SA
Summary
This study, with N = 85 participants minimum over 3 visits spread over 7 days, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G1-US for up to 7 days after initialization in a cohort of subjects representative of the US population.
Official title: OBPM_PANDA2026: Pivotal Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring (OBPM) Device at Wrist Against Double Auscultation: a Multicenter Prospective Clinical Study
Key Details
Gender
All
Age Range
22 Years - 59 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-04-20
Completion Date
2026-12-31
Last Updated
2026-04-17
Healthy Volunteers
Yes
Conditions
Interventions
Device under test evaluation against references
Blood pressure and pulse rate measurements will be taken at different timepoints with the device under test and references. Main references: Cuff for double auscultation for blood pressure and Electrocardiogram for pulse rate.
Locations (1)
Parameters Research Laboratory
Broomfield, Colorado, United States