At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Trial Testing the BioSerenity Pulse Oximeter (EOXY) Efficacy, Performance and Safety in Healthy Volunteer
In Brief
A clinical study evaluating EOXY device, Gold standard oximeter, and 1 other intervention for Healthy. Completed, enrolled 13 participants across 1 site.
Detailed Summary
The purpose of the study is to test the performance and safety of the Bioserenity pulse oxymeter EOXY. For that, and in agreement with ISO60601-2-61 norm and FDA regulation, measures of heart rate, with a gold-standard, and SaO2 measures generated by blood samples will be compared with Sp02 and heart rate measures that are generated by our EOXY. Thirteen healthy subjects will participate in the study in total. Three subjects will be enrolled during a primary phase .They will participate at a secondary phase as well as ten others subjects. The purpose of the primary phase is to test the body area where the measurement can be done. The purpose of the secondary phase is to measure SpO2 and HR in desaturation conditions.
Study Details
Timeline
Interventions
Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard