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

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ClinicalTrials.gov Identifier: NCT04610450
Recruitment Status : Enrolling by invitation
First Posted : October 30, 2020
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sensorineural Hearing Loss Device: HEARO Device: OTOPLAN Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation
Actual Study Start Date : April 26, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Relative ratio of successful electrode array insertions through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures. [ Time Frame: day 0 ]
    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.


Secondary Outcome Measures :
  1. Electrode array insertion outcome [ Time Frame: day 0 ]
    The angular insertion depth (in degrees) will be evaluated.

  2. Electrode array insertion outcome [ Time Frame: day 0 ]
    The number of inserted electrode contacts will be evaluated.

  3. Electrode array insertion outcome [ Time Frame: day 0 ]
    The surgical outcome (categories: nominal, tip-fold over or scalar deviation) will be evaluated.

  4. Insertion depth prediction accuracy [ Time Frame: day 0 ]
    The insertion depth prediction accuracy as the difference between the estimated insertion depth of the electrode at the planning and the actual insertion depth.

  5. Absolute angular accuracy of the drilled tunnel access [ Time Frame: day 0 ]
    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.

  6. Absolute lateral accuracy of the drilled tunnel at the facial recess [ Time Frame: day 0 ]
    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.

  7. Absolute lateral accuracy of the drilled tunnel at the target [ Time Frame: day 0 ]
    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.

  8. Ratio of the round window membrane preservation during the inner ear access [ Time Frame: day 0 ]
    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.

  9. Timing of the HEARO procedure [ Time Frame: day 0 ]
    The timing of the different steps of the HEARO procedure will be recorded.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04610450


Locations
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Switzerland
Inselspital, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Marco Caversaccio, Prof. Dr. University Hospital Bern (Inselspital)
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04610450    
Other Study ID Numbers: RCI-NEXT
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases