Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT06934005
Status:
COMPLETED
Last Update Posted:
2025-04-18
First Post:
2025-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part II
Sponsor:
UNEEG Medical A/S
Organization:
Study Overview
Official Title:
Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part II
Status:
COMPLETED
Status Verified Date:
2025-04
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 purpose of this clinical investigation is to test the safety and performance of one short- and one long-term Baseplate constructed with different types of biocompatible adhesives.
Detailed Description:
This clinical investigation intended to test different biocompatible adhesives over time as part of the UNEEG Episight Baseplate construction for UNEEG™ medical A/S.
The two Baseplates reported on in this registration, is a follow-up to an initial testing of four different types of adhesive i.e., four types of Baseplates.
This study is Part II of the protocol. Part I is registered: NCT05111847
The two Baseplates reported on in this registration, is a follow-up to an initial testing of four different types of adhesive i.e., four types of Baseplates.
This study is Part II of the protocol. Part I is registered: NCT05111847
Study Oversight
Has Oversight DMC:
False
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?: