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
|Condition or disease||Intervention/treatment||Phase|
|Sensorineural Hearing Loss||Device: HEARO Device: OTOPLAN||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Robot assisted cochlear implant surgery.
Robotic system for otological procedures
Otological surgical planning software
- 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.
- Electrode array insertion outcome [ Time Frame: day 0 ]The angular insertion depth (in degrees) will be evaluated.
- Electrode array insertion outcome [ Time Frame: day 0 ]The number of inserted electrode contacts will be evaluated.
- Electrode array insertion outcome [ Time Frame: day 0 ]The surgical outcome (categories: nominal, tip-fold over or scalar deviation) will be evaluated.
- 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.
- 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.
- 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.
- 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.
- 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.
- Timing of the HEARO procedure [ Time Frame: day 0 ]The timing of the different steps of the HEARO procedure will be recorded.
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
|Inselspital, Bern University Hospital|
|Bern, Switzerland, 3010|
|Principal Investigator:||Marco Caversaccio, Prof. Dr.||University Hospital Bern (Inselspital)|