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

ConditionHypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-59
SponsorAktiia SA

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Device under test evaluation against references

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators