OBPM_PANDA2026: Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring Device
Recruiting
N/AInterventional Study
Hypertension
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
22 – 59
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
200 (estimated)
Sponsor
Aktiia SA · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
1. Participants must be able to provide informed consent to participate.
2. Participants must be willing and able to comply with all of the study procedures and return for a second visit one week later.
3. Participants must be 22 to 59 years of age.
4. Participants or witnesses …
Inclusion Criteria:
1. Participants must be able to provide informed consent to participate.
2. Participants must be willing and able to comply with all of the study procedures and return for a second visit one week later.
3. Participants must be 22 to 59 years of age.
4. Participants or witnesses must be able to read or write in English.
Exclusion Criteria:
5. 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.)
6. 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 .
7. Participants with known history of clotting disorders or blood clots, or currently taking a prescription blood thinner.
8. Other known health conditions that will prevent safe participation in the study upon disclosure in Health Assessment Short Form or verbally.
9. 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.
10. 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.
11. A wrist circumference below 14 cm or above 23 cm.
12. An upper-arm circumference \<22 cm or \> 42cm.
13. Any subject that, in the opinion of the investigator, does not exhibit any phenotype relevant to the objectives of this study.
14. 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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.