CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 19 enrolled
Drug / intervention
Controlled desaturation studyother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04810221
NCT04810221N/ACompleted
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Postmarket Clinical Follow-up Study (PMCF) to Confirm the Performance of the Wearable Pulse-Oximeter BrOxy M

Life Meter srl·interventional·Posted Mar 22, 2021·Updated Apr 20, 2022

In Brief

A clinical study evaluating Controlled desaturation study for Laboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy M. Completed, enrolled 19 participants across 1 site.

Detailed Summary

This study is a post market clinical follow up study performed to confirm the performance of BrOxy M pulse oximeter in comparison with a reference, CE marked, pulse oximeter equipment in a controlled desaturation study over a range between 80% and 100% peripheral oxygen saturation (SpO2). The study will be performed on a group of healthy volunteers in a controlled clinical setting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLaboratory Testing on Healthy Volunteers to Verify SpO2 and Heart Rate (HR) Accuracy of BrOxy M
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 22, 2021
Enrollment StartMar 24, 2021
Primary CompletionApr 12, 2021
TodayJul 2, 2026
Enrollment to primary: 18 daysPosted 5.3 years ago

Interventions

Controlled desaturation studyother

Measure of SpO2 and Heart Rate by BrOxy M device and reference device in a controlled desaturation study.