Status:
COMPLETED
Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring Device At Wrist Against Double Auscultation
Lead Sponsor:
Aktiia SA
Conditions:
Hypertension
Eligibility:
All Genders
22-59 years
Phase:
NA
Brief Summary
This study, with N = 85 participants minimum over 3 visits spread over 23 hours, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Akti...
Eligibility Criteria
Inclusion
- Participants must be able to provide an informed consent to participate.
- Participant must be willing and able to comply with all of the study procedures and return for a day 2 visit.
- Participants must be 22 to 59 years of age.
- Participant or witness must be able to read or write in English.
Exclusion
- 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 day 1 positive urine pregnancy test unless the study participant is known to be not of child-bearing potential.
- Participants with known clotting disorders 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 sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest \> 120bpm) and atrial fibrillation.
- Participants suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR \< 60mL / min / 1.73 m2), hyper- / hypothyroidism, pheochromocytoma or arteriovenous fistula.
- A wrist circumference below 14 cm or above 23 cm.
- An upper arm circumference \< 22cm 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, 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.
Key Trial Info
Start Date :
September 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06565780
Start Date
September 23 2024
End Date
January 10 2025
Last Update
February 18 2025
Active Locations (1)
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1
Parameters Research Laboratory
Broomfield, Colorado, United States, 80021