OBPM_PANDA2026: Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pre… (NCT07507903) | Clinical Trial Compass
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OBPM_PANDA2026: Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring Device
United States200 participantsStarted 2026-04-20
Plain-language 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.
Who can participate
Age range22 Years – 59 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
0. 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.
✕1. A wrist circumference below 14 cm or above 23 cm.
✕2. An upper-arm circumference \<22 cm or \> 42cm.