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

Sensorineural Hearing Loss, Bilateral Clinical Trial

Official title:

The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04777565
• Other study ID #: MED-EL_HEARO_french_study
• Status: Completed
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: February 2023
• Source: MED-EL Elektromedizinische Geräte GesmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objectives of this study are to explore the efficacy and safety of a robotic procedure for a minimally invasive cochlear implantation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss, Bilateral

Intervention

Other:
• Robotic surgery
Cochlear implant surgery with HEARO procedure

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
MED-EL Elektromedizinische Geräte GesmbH

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrode array insertion	• 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).	During surgery
Secondary	Electrode array insertion outcome (efficacy)	• The angular insertion depth will be evaluated.	During surgery
Secondary	Electrode array insertion outcome (efficacy)	• The number of contacts inserted will be evaluated.	During surgery
Secondary	Electrode array insertion outcome (efficacy)	• The tip-fold over will be evaluated.	During surgery
Secondary	Electrode array insertion outcome (efficacy)	• The scalar deviation will be evaluated.	During surgery
Secondary	Insertion depth prediction accuracy (efficacy)	• The insertion depth prediction accuracy as the difference between the estimated insertion depth of the electrode at the planning and the actual insertion depth.	During surgery
Secondary	Absolute angular accuracy of the drilled tunnel access (safety)	• 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.	During surgery
Secondary	Absolute lateral accuracy of the drilled tunnel at the target (safety)	• 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.	During surgery
Secondary	Ratio of the round window membrane preservation during the inner ear access (safety)	• 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.	During surgery
Secondary	Timing of the HEARO procedure	• The timing of the different steps of the HEARO procedure will be recorded.	During surgery
Secondary	Adverse events (safety)	• Adverse events will be recorded	During surgery