RecruitingNot ApplicableNCT07507903

OBPM_PANDA2026: Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring Device

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

Sponsor

Aktiia SA

Enrollment

200 participants

Start Date

Apr 14, 2026

Study Type

INTERVENTIONAL

Conditions

Hypertension

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.

Eligibility

Min Age: 22 YearsMax Age: 59 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Device under test evaluation against references for people with hypertension. The study is currently recruiting participants at 1 location. People eligible for this study include aged 22 Years to 59 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDevice 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

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NCT07507903

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