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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Blood pressure mean value of differences [Срок оценки: 7 days]
• Blood pressure standard deviation of differences [Срок оценки: 7 days]

Вторичные конечные точки (1)

• Heart rate root-mean-square error [Срок оценки: 7 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Parameters Research Laboratory — Broomfield

Идентификаторы

NCT: NCT07507903 · OBPM_PANDA2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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