Ignite Creation Date:
2024-05-06 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05245942
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2021-12-22
Brief Title:
Monitoring of the Safety and the Performance of the Endoscopic Cap Electrode ECE50
Sponsor:
MED-EL Elektromedizinische Geräte GesmbH
Organization:
MED-EL Elektromedizinische Geräte GesmbH
Study Overview
Official Title:
Monitoring of the Safety and the Performance of the Endoscopic Cap Electrode ECE50
Status:
RECRUITING
Status Verified Date:
2024-03
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:
ECE50
Brief Summary:
The objective of this registry is to confirm the safety and the performance of the ECE50 in medical routine by collecting data
Detailed Description:
The Endoscopic Cap Electrode ECE50 has been designed for the delivery of electrostimulation to selected laryngeal muscles The primary objective of this registry is to retrieve real-life data on the safety and performance of the Endoscopic Cap in medical routine Subjects participation will last a maximum of 2 hours Upon successful conclusion of the screening session starts the testing session of the ECE50 The ECE50 has been designed to be placed on the top of a videoendoscope for the delivery of electrostimulation to the laryngeal region The stimulation and reaction of the muscles can provide information about the presence and type of dysfunctions and thus influence the treatment procedure Being a registry a collection of records generated within routine medical procedures with a medical device approved for the EU market it does not pose additional risks for the patients participating in it
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