Sensorineural Hearing Loss
Conditions
Brief summary
To study the efficacy of a minimally invasive direct cochlear access via the HEARO procedure.
Interventions
Sponsors
Prof. Vedat Topsakal
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
SIngle arm study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.
Exclusion criteria
* Age under 18 years * Pregnancy * Distance of the planned trajectory to the facial nerve is \< 0.4mm * Distance of the planned trajectory to the chorda tympani is \< 0.3mm * Vulnerability * Invalid or withdrawn informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The relative ratio of the electrode array insertion into the cochlea through the drilled direct cochlea access with HEARO procedure. (Efficacy) | Image data aquired during the procedure | 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 (%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of correctlly inserted electrode contact (Efficacy) | The procedure (day 0) | 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) |
| Insertion depth prediction accuracy (Efficacy) | The procedure (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. (Degrees °) |
| Absolute angular accuracy of the drilled tunnel access | The procedure (day 0) | 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. |
| Electrode array insertion depth (Efficacy) | The procedure (day 0) | The electrode insertion depth will be measured in the post-operative image. (Degrees °) |
| Absolute lateral drilling accuracy of the drilled tunnel at the target (Safety) | The procedure (day 0) | The absolute lateral accuracy of the drilled tunnel is measured as the distance between the planned and actual target position. (mm) |
| Evaluation of the automatic landmark detection (Performance) | The procedure (day 0) | 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) |
| Absolute lateral drilling accuracy of the drilled tunnel at the level of facial recess (Safety) | The procedure (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 and the actual distance. (mm) |
Countries
Belgium
Contacts
Primary ContactVedat Topsokal, Prof
Backup ContactPaul Van de Heyning, Prof
Outcome results
None listed