Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT03865316
Status:
COMPLETED
Last Update Posted:
2022-04-11
First Post:
2019-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia
Sponsor:
Masimo Corporation
Organization:
Study Overview
Official Title:
Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia
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:
None
Brief Summary:
The primary objective is to compare the performance of Masimo's SedLine and the comparator's device systems during surgery. Relative accuracy of the individual depth of sedation indices will be compared.
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?: