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NCT05528042: COBOX

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

Status unknown NA Last updated 6 September 2022
What this trial tests

NA trial testing Heart rate and respiratory rate measurement in Anyone Who Meets the Eligibility Criteria Can Use the Software in 323 participants. Status unknown.

Timeline
9 September 2022
Primary endpoint
19 September 2022
19 September 2022

Quick facts

Lead sponsorQuantiq.io
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment323
Start date9 September 2022
Primary completion19 September 2022
Estimated completion19 September 2022

Drugs / interventions tested

Conditions studied

Sponsor

Quantiq.io

Who can join

18 and older, any sex, with Anyone Who Meets the Eligibility Criteria Can Use the Software. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05528042.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing