Parameters Research Laboratory
Broomfield, Colorado, 80021, United States
NCT Number: NCT07507903
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.
Trial opening soon.
Get Notified22 year–59 year
All sexes
Interventional
Not applicable
Broomfield, Colorado, 80021, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 7 days
The mean value of the differences between Aktiia.product-G1-US and double auscultation blood pressure measurements.
Time frame: 7 days
The standard deviation of the differences between Aktiia.product-G1-US and double auscultation blood pressure measurements.
Time frame: 7 days
The root-mean-square difference between the Aktiia.product-G1-US heart rate determinations and the reference method.
Contact information is provided by the study sponsor or research team.
Aktiia SA
Industry
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
Acronym: OBPM_PANDA2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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