NCT06368206

Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM)

Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM) Algorithm That Requires No Calibration with an External Cuff: a Single-center Prospective Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Aktiia SA · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The present study, OBPM\_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational system together with several reference systems within a cohort of subjects characterized by a wide variety of phenotypes.

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	Investigational device Aktiia G2C	Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia G2C.
DEVICE	Marketed device used as reference for blood pressure monitoring: double auscultation cuff	Study subjects are asked to stay seated and relaxed while successive measurements are taken with cuff for double auscultation.
DEVICE	Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2	Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia Bracelet G2.
DEVICE	Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff	Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric upper-arm cuff.
DEVICE	Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff	Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric wrist cuff.
DEVICE	Marketed device used as reference for pulse rate monitoring: pulse finger oximeter	Study subjects are asked to stay seated and relaxed while successive measurements are taken with pulse finger oximeter.

Timeline

• Start date: 2024-06-25
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-04-16
• Last updated: 2024-12-17

Locations

1 site across 1 country: Switzerland