HypertensionOBPM_PANDA2026NCT07507903
OBPM_PANDA2026: Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring Device
A study testing Device under test evaluation against references in people with Hypertension, run by Aktiia SA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Device under test evaluation against references
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2026to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be able to provide informed consent to participate.
- Participants must be willing and able to comply with all of the study procedures and return for a second visit one week later.
- Participants must be 22 to 59 years of age.
- Participants or witnesses must be able to read or write in English.
Who cannot join
- Participants with compromised circulation, injury, or physical malformation of the equipment test sites or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
- Female participants who are known to be pregnant or who are trying to get pregnant confirmed by a visit 1 and, if applicable, visit 2 positive urine pregnancy test, unless the study participants are known to be not of child-bearing potential .
- Participants with known history of clotting disorders or blood clots, or currently taking a prescription blood thinner.
- Other known health conditions that will prevent safe participation in the study upon disclosure in Health Assessment Short Form or verbally.
- Participants suffering from sporadic or sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including but not limited to tachycardia (heart rate at rest > 120bpm) and atrial fibrillation.
- Participants suffering from sporadic or sustained reduction of peripheral perfusion that can lead to weak or unstable pressure pulses including but not limited to: Raynaud's disease, diabetes (Type I and Type II), renal dysfunctions (eGFR < 60mL / min / 1.73 m2), hyper- / hypothyroidism, pheochromocytoma, arteriovenous fistula, and valvular heart diseases.
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- A wrist circumference below 14 cm or above 23 cm.
- An upper-arm circumference <22 cm or > 42cm.
- Any subject that, in the opinion of the investigator, does not exhibit any phenotype relevant to the objectives of this study.
- Any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, or bias the results, by instance a subject presenting a lateral Blood Pressure difference at screening of more than 15 mmHg for the systolic and/or more than 10 mmHg for the diastolic.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Parameters Research Laboratory
Broomfield, Colorado, 80021
Arthur Cabrera Dr Med., 303-993-5217, art@parameterslab.com
About this study
Official title: 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
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.
- Conditions
- Hypertension
- Being tested
- Device under test evaluation against references
- Keywords
- blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device under test evaluation against referencesDevice
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 group | Role | What they receive |
|---|---|---|
| Aktiia.product-G1-US device under test | Other | Blood pressure and pulse rate measurements will be taken at different timepoints with the device under test and references. Receives: Device: Device under test evaluation against references |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure mean value of differences
The mean value of the differences between Aktiia.product-G1-US and double auscultation blood pressure measurements.
Measured: 7 days
Blood pressure standard deviation of differences
The standard deviation of the differences between Aktiia.product-G1-US and double auscultation blood pressure measurements.
Measured: 7 days
Secondary outcomes (1)
Heart rate root-mean-square error
The root-mean-square difference between the Aktiia.product-G1-US heart rate determinations and the reference method.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start14 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aktiia SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507903
- Sponsor's protocol ID
- OBPM_PANDA2026
- Acronym
- OBPM_PANDA2026
- Status last verified
- Sep 2026
- First submitted
- 27 Mar 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided