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NOT YET RECRUITING
NCT07507903
NA

OBPM_PANDA2026: Pivotal Evaluation of the Performance and Safety of the Aktiia Periodic Awake Optical Blood Pressure Monitoring (OBPM) Device at Wrist Against Double Auscultation: a Multicenter Prospective Clinical Study

Sponsor: Aktiia SA

View on ClinicalTrials.gov

Summary

This study, with N = 85 participants minimum over 2 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. For the study, subjects will be asked to assume various body positions while measurements are taken at different timepoints.

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

2026-04-02

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Device under test evaluation against references

Subjects will be asked to assume different body positions while blood pressure and pulse rate measurements are taken at different timepoints with the device under test and references. Device under Test: Aktiia.product-G1-US, Main references: Cuff for double auscultation for blood pressure and Electrocardiogram for pulse rate.

Locations (1)

Parameters Research Laboratory

Broomfield, Colorado, United States