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

Primary Purpose

Sensorineural Hearing Loss, Bilateral

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Robotic surgery
Sponsored by
MED-EL Elektromedizinische Geräte GesmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sensorineural Hearing Loss, Bilateral focused on measuring cochlear implant, robotic surgery, electrode insertion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Montpellier

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CI surgery

Arm Description

cochlear implant surgery

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Electrode array insertion outcome (efficacy)
• The angular insertion depth will be evaluated.
Electrode array insertion outcome (efficacy)
• The number of contacts inserted will be evaluated.
Electrode array insertion outcome (efficacy)
• The tip-fold over will be evaluated.
Electrode array insertion outcome (efficacy)
• The scalar deviation will be evaluated.
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.
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.
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.
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.
Timing of the HEARO procedure
• The timing of the different steps of the HEARO procedure will be recorded.
Adverse events (safety)
• Adverse events will be recorded

Full Information

First Posted
February 10, 2021
Last Updated
February 20, 2023
Sponsor
MED-EL Elektromedizinische Geräte GesmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04777565
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MED-EL Elektromedizinische Geräte GesmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss, Bilateral
Keywords
cochlear implant, robotic surgery, electrode insertion

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CI surgery
Arm Type
Experimental
Arm Description
cochlear implant surgery
Intervention Type
Other
Intervention Name(s)
Robotic surgery
Intervention Description
Cochlear implant surgery with HEARO procedure
Primary Outcome Measure Information:
Title
Electrode array insertion
Description
• 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).
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Electrode array insertion outcome (efficacy)
Description
• The angular insertion depth will be evaluated.
Time Frame
During surgery
Title
Electrode array insertion outcome (efficacy)
Description
• The number of contacts inserted will be evaluated.
Time Frame
During surgery
Title
Electrode array insertion outcome (efficacy)
Description
• The tip-fold over will be evaluated.
Time Frame
During surgery
Title
Electrode array insertion outcome (efficacy)
Description
• The scalar deviation will be evaluated.
Time Frame
During surgery
Title
Insertion depth prediction accuracy (efficacy)
Description
• The insertion depth prediction accuracy as the difference between the estimated insertion depth of the electrode at the planning and the actual insertion depth.
Time Frame
During surgery
Title
Absolute angular accuracy of the drilled tunnel access (safety)
Description
• 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.
Time Frame
During surgery
Title
Absolute lateral accuracy of the drilled tunnel at the target (safety)
Description
• 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.
Time Frame
During surgery
Title
Ratio of the round window membrane preservation during the inner ear access (safety)
Description
• 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.
Time Frame
During surgery
Title
Timing of the HEARO procedure
Description
• The timing of the different steps of the HEARO procedure will be recorded.
Time Frame
During surgery
Title
Adverse events (safety)
Description
• Adverse events will be recorded
Time Frame
During surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Venail, Pr
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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