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Clinical Trial Summary

This is a confirmatory study without any intervention. It is an uncontrolled, non-randomized and open-label study with measurements made with comparators, and it has a preset hypothesis for the primary endpoint. There are no similar devices to VitalThings Guardian M10 / M10 mobile on the market, consequently one or more different types of devices must be used as comparators.


Clinical Trial Description

The purpose of the clinician investigation is to validate a claim made for the investigational device performance. The objective is to confirm that the device performs at +/- 1.2 respirations per minute (RPM) accuracy against the identified comparator device, and compare performance to the standard of care as documented in the literature. The study will be conducted with patients admitted to the emergency ward after the initial treatment and examination. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06083272
Study type Observational
Source VitalThings
Contact
Status Completed
Phase
Start date November 15, 2023
Completion date November 28, 2023

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