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NCT06368206 Clinical Trial

Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring (OBPM) Device at Fingertip (Aktiia G2C) Against Double Auscultation, and Comparison With Oscillometry and Aktiia Bracelet G2

Hypertension Clinical Trial

Official title:
Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring (OBPM) Device at Fingertip (Aktiia G2C) Against Double Auscultation, and Comparison With Oscillometry and Aktiia Bracelet G2: a Single-center Prospective Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06368206
Other study ID # OBPM_Calfree2024
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 15, 2024
Est. completion date December 31, 2024

Study information
Verified date April 2024
Source Aktiia SA
Contact Grégoire Wuerzner, Medical Doctor Prof.
Phone +41213140223
Email gregoire.wuerzner@chuv.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present study, OBPM_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to evaluate the performances and safety of the Aktiia.product-G2C that doesn't require any calibrations, as compared against double auscultation for BP reference measurements, and finger pulse oximeter for pulse rate reference measurements, for a cohort of subjects characterized by a wide variety of phenotypes.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 85
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 85 Years
Eligibility Inclusion Criteria: - Subjects aged 21 to 85yo - Subjects fluent in written and spoken French - Subjects agreeing to attend the study visit and follow study procedures - Subjects that have signed the informed consent form. Exclusion Criteria: - Amputated index fingers - Damaged/injured skin at index fingers - Damaged/injured skin at wrists - Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest > 120bpm) and atrial fibrillation - Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 30mL/min/1.73 m2), hyper-/hypothyroidism, pheochromocytoma or arteriovenous fistula - Pregnant women - Polyneuropathy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Investigational device Aktiia G2C
Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia G2C.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations
Country Name City State
Switzerland CHUV Lausanne

Sponsors (1)
Lead Sponsor Collaborator
Aktiia SA

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood pressure mean value of differences The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements. Day 1
Primary Blood pressure standard deviation of differences The standard deviation of the differences between Aktiia G2C and double auscultation blood pressure measurements Day 1
Secondary Pulse rate root-mean-square error The root-mean-square difference between the Aktiia G2C pulse rate determinations and the reference method. 1 hour
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