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
Not Yet Recruiting

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Conditions

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

Start date
Apr 20, 2026
Status verified
Apr 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.

Primary Outcome Measure

Blood pressure mean value of differences [ Time Frame: 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Parameters Research LaboratoryBroomfieldColorado80021
Arthur Cabrera Dr Med.
[email protected]
303-993-5217

Find similar trials in Broomfield, CO

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Parameters Research Laboratory· Broomfield, CO

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