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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)

NCT06368206 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2024-12-17

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Aktiia SA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-25
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06368206 on ClinicalTrials.gov