The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation

The cochlear implant is a neural prosthesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. The surgical procedure for cochlear implantation 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 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 portions of the mastoid bone through a 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 performance of robotic cochlear implantation surgery.

Study Overview

• Status: Completed
• Conditions: Sensorineural Hearing Loss
• Intervention / Treatment: Device: HEARO; Device: OTOPLAN

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Bern University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects scheduled for CI surgery according to clinical routine
• Subjects who will receive a cochlear implant
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RCI-BE-10; Robot assisted cochlear implant surgery.	Device: HEARO; Robotic system for otological procedures; Device: OTOPLAN; Otological surgical planning software

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative ratio of successful electrode array insertions through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures.	The primary outcome measure of this study is to explore the relative ratio of the successful electrode array insertions into the cochlea through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures. Aborted or converted procedures count as procedure in which insertion through the direct cochlea access was not possible. The results will be expressed in relative numbers and in percentage.	day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrode array insertion outcome	The angular insertion depth (in degrees) will be evaluated.	day 0
Electrode array insertion outcome	The number of inserted electrode contacts will be evaluated.	day 0
Electrode array insertion outcome	The surgical outcome (categories: nominal, tip-fold over or scalar deviation) will be evaluated.	day 0
Insertion depth prediction accuracy	The insertion depth prediction accuracy as the difference between the estimated insertion depth of the electrode at the planning and the actual insertion depth.	day 0
Absolute angular accuracy of the drilled tunnel access	The absolute in-plane and out-plane accuracy of the drilled tunnel is measured as the angular deviation between the planned trajectory in-plane and out-plane angles and the actual drilled angles from the intra-op image.	day 0
Absolute lateral accuracy of the drilled tunnel at the facial recess	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.	day 0
Absolute lateral accuracy of the drilled tunnel at the target	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.	day 0
Ratio of the round window membrane preservation during the inner ear access	The ratio of the visibility of round window membrane surface at the robotic inner ear access by visual inspection. This will be assessed as subjective evaluation by the surgeon.	day 0
Timing of the HEARO procedure	The timing of the different steps of the HEARO procedure will be recorded.	day 0

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Marco Caversaccio, Prof. Dr., University hospital Bern (Inselspital)

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2021
• Primary Completion (Actual): November 23, 2022
• Study Completion (Actual): November 23, 2022

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 25, 2022
• Last Update Submitted That Met QC Criteria: November 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural
• Other Study ID Numbers: RCI-NEXT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No