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Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring Device At Wrist Against Double Auscultation

NCT06565780 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-02-18

No results posted yet for this study

Summary

This study, with N = 85 participants minimum over 3 visits spread over 23 hours, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G0 for up to 23 hours after initialization in a cohort of subjects representative of the US population.

For the study, subjects will be asked to stay seated while measurements are taken at different timepoints.

Conditions

Interventions

DEVICE

Device under test evaluation against references

Subjects will be asked to stay seated while blood pressure and pulse rate measurements are taken at different timepoints with the device under test and references. Device under Test: Aktiia.product-G0 References: Cuff for double auscultation for blood pressure and Electrocardiogram for pulse rate.

Sponsors & Collaborators

  • Aktiia SA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-23
Primary Completion
2025-01-10
Completion
2025-01-10
FDA Device
Yes

Countries

  • United States

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 NCT06565780 on ClinicalTrials.gov