Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT05964166
Status:
COMPLETED
Last Update Posted:
2024-11-18
First Post:
2023-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tetragraph® Monitor: Tolerance of Preoperative Placement
Sponsor:
Joseph D. Tobias
Organization:
Study Overview
Official Title:
Tetragraph® Monitor: Tolerance of Preoperative Placement
Status:
COMPLETED
Status Verified Date:
2024-10
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:
This is a prospective, non-blinded, single arm study. The primary objective of this study is to evaluate the tolerance to preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor in pediatric-sized patients ≤ 12 years of age.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?: