Clinical trial NCT04610450: The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation
Official title: The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensorineural Hearing Loss
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Relative ratio of successful electrode array insertions through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures.
timeFrame: day 0
Secondary outcomes:
measure: Electrode array insertion outcome
timeFrame: day 0
measure: Electrode array insertion outcome
timeFrame: day 0
measure: Electrode array insertion outcome
timeFrame: day 0
measure: Insertion depth prediction accuracy
timeFrame: day 0
measure: Absolute angular accuracy of the drilled tunnel access
timeFrame: day 0
measure: Absolute lateral accuracy of the drilled tunnel at the facial recess
timeFrame: day 0
measure: Absolute lateral accuracy of the drilled tunnel at the target
timeFrame: day 0
measure: Ratio of the round window membrane preservation during the inner ear access
timeFrame: day 0
measure: Timing of the HEARO procedure
timeFrame: day 0
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Bern University Hospital
Study officials:
affiliation: University Hospital Bern (Inselspital)
name: Marco Caversaccio, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: