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Completed

NCT Number: NCT06565780

Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring Device At Wrist Against Double Auscultation

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 Aktiia.product-G0 for up to 23 hours after initialization in a cohort of subjects representative of the US population.

For the study, subjects will be asked to stay seated while measurements are taken at different timepoints.

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Key information

Age range

22 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parameters Research Laboratory

Broomfield, Colorado, 80021, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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 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.

Treatment and study plan

Device under test evaluation against references

Device

Subjects will be asked to stay seated while blood pressure and pulse rate measurements are taken at different timepoints with the device under test and references.

Device under Test: Aktiia.product-G0 References: Cuff for double auscultation for blood pressure and Electrocardiogram for pulse rate.

Primary outcomes

  1. Blood pressure mean value of differences

    Time frame: 23 hours

    The mean value of the differences between Aktiia.product-G0 and double auscultation blood pressure measurements.

  2. Blood pressure standard deviation of differences

    Time frame: 23 hours

    The standard deviation of the differences between Aktiia.product-G0 and double auscultation blood pressure measurements.

Secondary outcomes

  1. Heart rate root-mean-square error

    Time frame: 23 hours

    The root-mean-square difference between the Aktiia.product-G0 heart rate determinations and the reference method.

Sponsors and collaborators

Lead sponsor

Aktiia SA

Industry

Registry information

Official study title

Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring (OBPM) Device At Wrist Against Double Auscultation: a Multicentric Prospective Clinical Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2024
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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