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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 - Trial NCT06368206

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.

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ClinicalTrials.gov โ€ข NCT06368206
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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

Study Focus

Hypertension

Investigational device Aktiia G2C

Interventional

device

Sponsor & Location

Aktiia SA

Lausanne, Switzerland

Timeline & Enrollment

N/A

May 15, 2024

Dec 31, 2024

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 diseases
Renovascular hypertension
Secondary hypertension
Other secondary hypertension
Hypertensive heart disease

Data Source

ClinicalTrials.gov

NCT06368206

Device Trial