Not yet recruiting NCT07507903
OBPM_PANDA2026: Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring Device
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Device under test evaluation against references.
- Who it may be relevant to
- Registry conditions: Hypertension. Basic parameters: 22 years — 59 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device Device under test evaluation against references
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.
Primary outcome measures
- Blood pressure mean value of differences [Time frame: 7 days]
- Blood pressure standard deviation of differences [Time frame: 7 days]
Secondary outcome measures (1)
- Heart rate root-mean-square error [Time frame: 7 days]
Eligibility criteria
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.
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Parameters Research Laboratory — Broomfield
Identifiers
NCT: NCT07507903 · OBPM_PANDA2026