Clinical trial NCT04777565: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensorineural Hearing Loss, Bilateral
Keywords: cochlear implant
robotic surgery
electrode insertion
Lead sponsor: MED-EL Elektromedizinische Geräte GesmbH
Sponsor class: INDUSTRY
First posted: 2021-03-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Electrode array insertion
timeFrame: During surgery
Secondary outcomes:
measure: Electrode array insertion outcome (efficacy)
timeFrame: During surgery
measure: Electrode array insertion outcome (efficacy)
timeFrame: During surgery
measure: Electrode array insertion outcome (efficacy)
timeFrame: During surgery
measure: Electrode array insertion outcome (efficacy)
timeFrame: During surgery
measure: Insertion depth prediction accuracy (efficacy)
timeFrame: During surgery
measure: Absolute angular accuracy of the drilled tunnel access (safety)
timeFrame: During surgery
measure: Absolute lateral accuracy of the drilled tunnel at the target (safety)
timeFrame: During surgery
measure: Ratio of the round window membrane preservation during the inner ear access (safety)
timeFrame: During surgery
measure: Timing of the HEARO procedure
timeFrame: During surgery
measure: Adverse events (safety)
timeFrame: During surgery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Frédéric Venail, Pr
role: PRINCIPAL_INVESTIGATOR
References: