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Validation of the Performance of the COBOX Solution for Measuring Heart Rate and Respiratory Rate

NCT05528042 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2022-09-06

No results posted yet for this study

Summary

Quantiq.io "COBOX" is a software as a medical device. It relies on remote photoplethysmography, allowing for the remote measurement of a patient's physiological parameters from a healthcare professional's or patient's device which can be a smartphone, a computer or a health station with an optical camera.

Quantiq.io software is a medical device which is :

contactless for the measurement non-invasive for the patient

In order to meet safety and quality standards, new health technologies require rigorous clinical validation with measurement performance at least equivalent to that of one CE marking measure device.

In this context, we assume that the COBOX device will take measurements of heart and respiratory rates equivalent to those taken by medical devices and current practices.

Conditions

  • Anyone Who Meets the Eligibility Criteria Can Use the Software

Interventions

OTHER

Heart rate and respiratory rate measurement

Validation of the performance of the heart rate (HR) measurement using COBOX medical device compared to a measurement carried out by applying the reference processes for taking measurements via a CE marked device. Evaluation of the performance of the respiratory rate (RR) measurement using COBOX medical device compared to a measurement carried out by a reference method of manual counting

Sponsors & Collaborators

  • Quantiq.io

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-09
Primary Completion
2022-09-19
Completion
2022-09-19

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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 NCT05528042 on ClinicalTrials.gov