Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810221
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2021-03-18
Brief Title:
Postmarket Clinical Follow-up Study to Confirm the Performance of the Wearable Pulse-Oximeter BrOxy M SOMBRERO
Sponsor:
Life Meter srl
Organization:
Life Meter srl
Study Overview
Official Title:
Postmarket Clinical Follow-up Study PMCF to Confirm the Performance of the Wearable Pulse-Oximeter BrOxy M
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOMBRERO
Brief 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
The study will be performed on a group of healthy volunteers in a controlled clinical setting
Detailed Description:
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 Nellcor Bedside Respiratory Patient Monitoring System model PM1000N Covidien LLC USA in a controlled desaturation study over a range between 80 and 100 SpO2
The study will be performed on a group of healthy volunteers in a controlled clinical setting Due to the use of a controlled desaturation protocol foreseen by the standard ISO 80601-2-612017 this study is classified as an interventional post-market clinical study in accordance with Annex I of EN ISO 141552020
The study will be performed on a group of healthy volunteers in a controlled clinical setting Due to the use of a controlled desaturation protocol foreseen by the standard ISO 80601-2-612017 this study is classified as an interventional post-market clinical study in accordance with Annex I of EN ISO 141552020
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None