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

Part of paid clinical trials in Broomfield, Colorado.

Sponsor: Aktiia SA
Study ID: NCT07507903
Status: Recruiting

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Conditions

Hypertension

Eligibility Criteria

Sex: ALL
Age: 22 Years - 59 Years
Healthy Volunteers: Accepted

Interventions

Device under test evaluation against references — DEVICE
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.

Study Details

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.

Key Dates

First listed: Apr 2, 2026
Start date: Apr 14, 2026
Status verified: Sep 2026
Primary completion: Dec 31, 2026
Completion: Dec 31, 2026

Study Design

Enrollment: 200 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Arms

Other: Aktiia.product-G1-US device under test
Blood pressure and pulse rate measurements will be taken at different timepoints with the device under test and references.