NCT06565780

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Aktiia SA · Industry
• Sex: All
• Age: 22 Years – 59 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	Device under test evaluation against references	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.

Timeline

• Start date: 2024-09-23
• Primary completion: 2025-01-10
• Completion: 2025-01-10
• First posted: 2024-08-22
• Last updated: 2025-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study