Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT03710993
Status:
COMPLETED
Last Update Posted:
2018-10-18
First Post:
2018-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Accuracy Assessment of Beddr Oximeter
Sponsor:
Hancock Medical, Inc.
Organization:
Study Overview
Official Title:
Beddr Sleep SpO2 Equivalency Calibration Study
Status:
COMPLETED
Status Verified Date:
2018-10
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:
Accuracy performance of Beddr oximeter
Detailed Description:
This study will evaluate the accuracy of the Beddr sleepTuner oximeter compared to a transfer standard and multiple reference devices.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: