Brief Title
Study of a Minimally Invasive Cochlear Access for Cochlear Implantation Via a Robotic Procedure
Official Title
The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure
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.
Study Type
Interventional
Primary Outcome
Electrode array insertion
Secondary Outcome
Electrode array insertion outcome (efficacy)
Condition
Sensorineural Hearing Loss, Bilateral
Intervention
Robotic surgery
Study Arms / Comparison Groups
CI surgery
Description: cochlear implant surgery
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
10
Start Date
September 15, 2021
Completion Date
March 15, 2023
Primary Completion Date
September 15, 2022
Eligibility Criteria
Inclusion Criteria:
- Subjects scheduled for CI surgery according to clinical routine
- Subjects who will receive a cochlear implant of the MED-EL portfolio
- Signed and dated informed consent form
Exclusion Criteria:
- Lack of compliance with any inclusion criteria
- Age under 18 years
- Pregnancy
- Distance of the planned trajectory to the facial nerve is < 0.4 mm as per screening CT
scan
- Distance of the planned trajectory to the chorda tympani is < 0.3 mm as per screening
CT scan
- A safe inner ear access cannot be planned for preservation of RW membrane and cochlear
structures
- Individuals where image guidance or robotic procedures are not indicated
- Individuals who have known allergy to components of the cochlear implant
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Frédéric Venail, Pr, (+33)603592974, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04777565
Organization ID
MED-EL_HEARO_french_study
Responsible Party
Sponsor
Study Sponsor
MED-EL Elektromedizinische Geräte GesmbH
Study Sponsor
Frédéric Venail, Pr, Principal Investigator, University Hospital, Montpellier
Verification Date
December 2021