Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04886583
Status:
COMPLETED
Last Update Posted:
2022-04-04
First Post:
2021-05-03
Brief Title:
Assessment of the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for Continuous Vital Parameters Monitoring in Infants and Young Children
Sponsor:
Gabi SmartCare
Organization:
Gabi SmartCare
Study Overview
Official Title:
Preliminary Multi-centric Clinical Study Assessing the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for the Continuous Monitoring and Recording of Vital Physiological Parameters on Infants and Young Children by Comparison of Simultaneous Polysomnographic Recording During Standard of Care Hospitalisation
Status:
COMPLETED
Status Verified Date:
2022-03
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:
WAGSC1
Brief Summary:
During a polysomnography test PSG previously prescribed by a physician the patient also wears the Gaby Baby Band GBB during an entire night of sleep After the test data from the device and from the PSG HR SpO2 BR will be saved and analysed in the aim to assess the actual accuracy of the GBB with golden standard values ECG Oximeter belly belt In a second analysis the aim is to improve the accuracy of the GBB algorithm
Detailed Description:
None
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