Study of a Minimally Invasive Cochlear Access for Cochlear Implantation Via a Robotic Procedure

Not Applicable

Completed

• Conditions: Sensorineural Hearing Loss, Bilateral
• Interventions: Other: Robotic surgery

• Registration Number: NCT04777565
• Lead Sponsor: MED-EL Elektromedizinische Geräte GesmbH

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 Timeline

• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-02
• Study Start: 2021-09-15
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CI surgery	Robotic surgery	cochlear implant surgery

Primary Outcome Measures

Name	Time	Method
Electrode array insertion	During surgery	• Relative ratio of successful electrode array insertions through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures (i.e. proportion of successful insertions with the procedure out of the total number of patients included in the study).

Secondary Outcome Measures

Name	Time	Method
Insertion depth prediction accuracy (efficacy)	During surgery	• The insertion depth prediction accuracy as the difference between the estimated insertion depth of the electrode at the planning and the actual insertion depth.
Adverse events (safety)	During surgery	• Adverse events will be recorded
Electrode array insertion outcome (efficacy)	During surgery	• The scalar deviation will be evaluated.
Timing of the HEARO procedure	During surgery	• The timing of the different steps of the HEARO procedure will be recorded.
Absolute lateral accuracy of the drilled tunnel at the target (safety)	During surgery	• The absolute lateral accuracy of the drilled tunnel is measured as the distance between the planned target trajectory position and actual target of the drilled trajectory position.
Absolute angular accuracy of the drilled tunnel access (safety)	During surgery	• The absolute lateral accuracy of the drilled tunnel to the facial nerve and chorda tympani is measured as the difference between the planned trajectory and the actual drilled trajectory distance.
Ratio of the round window membrane preservation during the inner ear access (safety)	During surgery	• The ratio of the preserved round window (RW) membrane at the robotic inner ear access by visual inspection. This will be assessed as subjective evaluation by the surgeon.

Trial Locations

Locations (1)

CHU Montpellier; 🇫🇷 Montpellier, France