Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04811300
Status:
COMPLETED
Last Update Posted:
2021-05-19
First Post:
2021-03-19
Brief Title:
mCVI Lighting Conditions Clinical Study
Sponsor:
Intelomed Inc
Organization:
Intelomed Inc
Study Overview
Official Title:
A Single-Center Prospective Clinical Study to Demonstrate That in 4 Different Lighting Conditions mCVI Accurately Captures Pulse Rate and Respiratory Rate in 10 Healthy Volunteers in Comparison to a Commercially-Available Masimo Pulse Oximeter Device
Status:
COMPLETED
Status Verified Date:
2021-05
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:
None
Brief Summary:
This single center prospective clinical study is to verify the algorithm of mCVI in 4 different lighting conditions to accurately capture pulse rate and respiratory rate in 10 healthy subjects in comparison to commercially-available Masimo pulse oximeter devices This is a non significant risk device
Detailed Description:
In this prospective clinical study the mCVI device is a mobile application used to simply verify the algorithm when the mobile video reads a patients pulse rate and respiratory rate while spontaneously breathing There is no facial recognition technology There is no immediate feedback given to the research team to act upon or provide for further clinical care decisions In real time the mCVI device will be compared to two commercially-available Masimo pulse oximeter devices in a single visit
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