To study the efficacy of a minimally invasive direct cochlear access via the HEARO procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Antwerp University Hospital
Antwerp, Belgium
RECRUITINGThe relative ratio of the electrode array insertion into the cochlea through the drilled direct cochlea access with HEARO procedure. (Efficacy)
The ratio of the number of the procedures in which it was possible to insert the electrode inside the cochlea through the direct cochlear access compared to the number of procedures in which the insertion through the direct cochlea access was not possible will be calculated. 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 (n of 25) and in percentage (%).
Time frame: Image data aquired during the procedure
Electrode array insertion depth (Efficacy)
The electrode insertion depth will be measured in the post-operative image. (Degrees °)
Time frame: The procedure (day 0)
Number of correctlly inserted electrode contact (Efficacy)
The number of inserted electrode contacts into the inner ear will be counted in the post-operative image. (Number n) * number of contacts inserted (n)
Time frame: The procedure (day 0)
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. (Degrees °)
Time frame: The procedure (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 and the actual angles.
Time frame: The procedure (day 0)
Absolute lateral drilling accuracy of the drilled tunnel at the level of facial recess (Safety)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The absolute lateral accuracy of the drilled tunnel to the facial nerve and chorda tympani is measured as the difference between the planned and the actual distance. (mm)
Time frame: The procedure (day 0)
Absolute lateral drilling 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 and actual target position. (mm)
Time frame: The procedure (day 0)
Evaluation of the automatic landmark detection (Performance)
The relative ratio of the automatically identified landmarks by OTOPLAN that were not manually adjusted by the surgeon. The intended landmarks are: * Middle ear cavity breakthrough * Bony overhang lateral wall * Bony overhang medial wall The absolute distance between the new position of the adjusted landmark to the position of the automatically identified landmark will be evaluated. (Number n)
Time frame: The procedure (day 0)