Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777565
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2021-02-10
Brief Title:
Study of a Minimally Invasive Cochlear Access for Cochlear Implantation Via a Robotic Procedure
Sponsor:
MED-EL Elektromedizinische Geräte GesmbH
Organization:
MED-EL Elektromedizinische Geräte GesmbH
Study Overview
Official Title:
The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure
Status:
COMPLETED
Status Verified Date:
2023-02
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 objectives of this study are to explore the efficacy and safety of a robotic procedure for a minimally invasive cochlear implantation
Detailed Description:
The cochlear implant CI is a neural prothesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades The surgical procedure for cochlear implantation surgery aims to atraumatically insert the electrode array of the cochlear implant into the cochlea However due to the location of the cochlea inside the skull the surgeon is required to initially create an access from the surface of the temporal bone to the cochlea inner ear In conventional methods this access is acquired by removal of large portions of the mastoid bone through a wide mastoidectomy and posterior tympanotomy The outcome and success of the conventional procedure varies due to mainly two factors surgeon skill and subject anatomical variation
To overcome these variables toward a more consistent and less invasive cochlear implantation surgery the development of robotic and image guided cochlear implantation has taken place
This study primarily aims to explore the efficacy of the HEARO robotic cochlear implantation surgery
Primary Objective
The primary objective of this study is to
explore the efficacy of a minimally invasive direct cochlear access via the HEARO procedure
Secondary Objectives
The secondary objectives of this study are to
explore the safety of a minimally invasive direct cochlear access via the HEARO procedure
exploratively evaluate the electrode array insertion outcomes through the direct tunnel access
To overcome these variables toward a more consistent and less invasive cochlear implantation surgery the development of robotic and image guided cochlear implantation has taken place
This study primarily aims to explore the efficacy of the HEARO robotic cochlear implantation surgery
Primary Objective
The primary objective of this study is to
explore the efficacy of a minimally invasive direct cochlear access via the HEARO procedure
Secondary Objectives
The secondary objectives of this study are to
explore the safety of a minimally invasive direct cochlear access via the HEARO procedure
exploratively evaluate the electrode array insertion outcomes through the direct tunnel access
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