Pure Global AI
NCT06368206Not yet recruiting

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

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
Aktiia SAClinicalTrials.govdeviceDevice trial
Verified
Study focus
Disease/Condition
Hypertension
Drug/Device/Intervention
Investigational device Aktiia G2C
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Aktiia SA
Location
Lausanne, Switzerland
Timeline & enrollment
Phase
N/A
Start date
May 15, 2024
End date
Dec 31, 2024
Enrollment
85 participants
Primary outcome

Blood pressure mean value of differences,Blood pressure standard deviation of differences

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.

ICD-10 classifications
Hypertensive diseasesRenovascular hypertensionSecondary hypertensionOther secondary hypertensionHypertensive heart disease
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06368206
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06368206 through Pure Global AI's free database. This phase not specified trial is sponsored by Aktiia SA and is currently Not yet recruiting. The study focuses on Hypertension. Target enrollment is 85 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.