Aktiia Blood Pressure Monitor Performance in a US Population

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial evaluates the accuracy and precision of the Aktiia Blood Pressure Monitor (product-G1-US) against reference measurements over up to seven days. It plans to enroll at least 85 participants who will have measurements taken over three visits within a seven-day period. Participants must be 22–59 years old, able to consent, and able to return for a second visit one week later. The study excludes individuals with conditions affecting test sites, pregnant individuals, and those with a clotting history that could impact sensor placement. The lead sponsor is Aktiia SA, with the Parameters Research Laboratory in Broomfield, Colorado serving as the study site.

Why it matters

Who can join: the full rules

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.

Where it's running

• Parameters Research Laboratory
  Broomfield, Colorado, United States Recruiting

Study contacts

• Study coordinator: Anne Fedor Chief Clinical Research Officer
• Email: anne@parameterslab.com
• Phone: 303-993-5217

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.