Clinical trial NCT03746613: Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques
Official title: Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensorineural Hearing Loss
Keywords: robot
Image guidance
Cochlear implantation
navigation
HEARO procedure
sensorineural hearing loss
inner ear access
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2018-11-19
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: To assess the feasibility of achieving a minimally invasive access to the inner ear through the navigation-based HEARO procedure and subsequently insert the electrode array of the cochlear implant through the access.

Detailed description: * Demonstrate the feasibility and efficacy of performing a middle and inner ear access for cochlear implantation procedures in adults.
* Validate the procedure workflow including imaging, planning, safety assessment, image to patient registration, robotic drilling, electrode insertion and device implantation.
* Validate the system and procedure safety mechanisms.
* Collect required data for validation of safety algorithms and procedure workflow optimisation.
* Validate the HEARO system.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from profound sensorineural deafness requiring a Cochlear implant

Exclusion Criteria:

* Age under 18 years
* Pregnant women
* Anatomical anomalies of temporal bone
* Chronic otitis media with or without cholesteatoma

Primary outcomes:
measure: The relative ratio of successfully completed procedures where a direct access tunnel was drilled to the cochlea with the HEARO® system and the electrode was conventionally inserted through the tunnel.
timeFrame: Image data aquired during the procedure
Secondary outcomes:
measure: Number of completed middle ear access
timeFrame: The procedure (day 0)
measure: Number of completed inner ear access
timeFrame: The procedure (day 0)
measure: Accuracy of the drilled trajectory
timeFrame: Image data aquired during the procedure
measure: Sensitivity and specificity of facial nerve monitoring
timeFrame: The procedure (day 0)
measure: Measurement of the insertion angle
timeFrame: Image data aquired during the procedure
measure: Number of tip fold-overs
timeFrame: The procedure (day 0)
measure: Number of Scala deviations
timeFrame: The procedure (day 0)
measure: Number of complication events on (temporary) facial nerve palsy, pre and post bleeding and infection
timeFrame: day 0-30
measure: Time of procedure
timeFrame: The procedure (day 0)
measure: Volume of tissue removed
timeFrame: Image data aquired during the procedure
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
Study officials:
References:
citation: Topsakal V, Heuninck E, Matulic M, Tekin AM, Mertens G, Van Rompaey V, Galeazzi P, Zoka-Assadi M, van de Heyning P. First Study in Men Evaluating a Surgical Robotic Tool Providing Autonomous Inner Ear Access for Cochlear Implantation. Front Neurol. 2022 Mar 21;13:804507. doi: 10.3389/fneur.2022.804507. eCollection 2022.